{
"NDC": [
{
"NDCCode": "50742-637-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-637-90) ",
"NDC11Code": "50742-0637-90",
"ProductNDC": "50742-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208947",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170831",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine extended-release tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (light yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients: The following are common in all 5 tablet strengths: microcrystalline cellulose, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Additional inactive ingredients include: 50 mg - polyvinyl alcohol, talc, iron oxide yellow, iron oxide red, iron oxide black, lecithin (soya);150 mg - polydextrose and triacetin; 200 mg - polyvinyl alcohol, talc, lecithin (soya), D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake; 300 mg - polyvinyl alcohol, talc, lecithin (soya), iron oxide yellow and iron oxide black; 400 mg - polydextrose, and triacetin. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. Meets USP dissolution test 6."
},
{
"NDCCode": "50742-637-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-637-10) ",
"NDC11Code": "50742-0637-10",
"ProductNDC": "50742-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208947",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170831",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine extended-release tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (light yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients: The following are common in all 5 tablet strengths: microcrystalline cellulose, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Additional inactive ingredients include: 50 mg - polyvinyl alcohol, talc, iron oxide yellow, iron oxide red, iron oxide black, lecithin (soya);150 mg - polydextrose and triacetin; 200 mg - polyvinyl alcohol, talc, lecithin (soya), D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake; 300 mg - polyvinyl alcohol, talc, lecithin (soya), iron oxide yellow and iron oxide black; 400 mg - polydextrose, and triacetin. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. Meets USP dissolution test 6."
},
{
"NDCCode": "50742-637-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-637-30) ",
"NDC11Code": "50742-0637-30",
"ProductNDC": "50742-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208947",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170831",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine extended-release tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (light yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients: The following are common in all 5 tablet strengths: microcrystalline cellulose, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Additional inactive ingredients include: 50 mg - polyvinyl alcohol, talc, iron oxide yellow, iron oxide red, iron oxide black, lecithin (soya);150 mg - polydextrose and triacetin; 200 mg - polyvinyl alcohol, talc, lecithin (soya), D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake; 300 mg - polyvinyl alcohol, talc, lecithin (soya), iron oxide yellow and iron oxide black; 400 mg - polydextrose, and triacetin. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. Meets USP dissolution test 6."
},
{
"NDCCode": "50742-637-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-637-60) ",
"NDC11Code": "50742-0637-60",
"ProductNDC": "50742-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208947",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170831",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine extended-release tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (light yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients: The following are common in all 5 tablet strengths: microcrystalline cellulose, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Additional inactive ingredients include: 50 mg - polyvinyl alcohol, talc, iron oxide yellow, iron oxide red, iron oxide black, lecithin (soya);150 mg - polydextrose and triacetin; 200 mg - polyvinyl alcohol, talc, lecithin (soya), D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake; 300 mg - polyvinyl alcohol, talc, lecithin (soya), iron oxide yellow and iron oxide black; 400 mg - polydextrose, and triacetin. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. Meets USP dissolution test 6."
},
{
"NDCCode": "34908-637-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-637-90) ",
"NDC11Code": "34908-0637-90",
"ProductNDC": "34908-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208947",
"LabelerName": "Novast Laboratories, Ltd.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170831",
"SamplePackage": "N"
},
{
"NDCCode": "43353-637-60",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (43353-637-60) ",
"NDC11Code": "43353-0637-60",
"ProductNDC": "43353-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine Hydrochloride",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075049",
"LabelerName": "Aphena Pharma Solutions - Tennessee, Inc.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Fluoxetine is a selective serotonin reuptake inhibitor indicated for: 1 Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1), 2 Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2), 3 Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3), 4 Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).",
"Description": "Fluoxetine capsules are a psychotropic drug for oral administration. They are also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). They are designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and have the empirical formula of C17H18F3NOHCl. The molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule, for oral administration, contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine. The inactive ingredients are: corn starch, gelatin, magnesium stearate, pregelatinized starch, propylene glycol, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. The 10 and 20 mg capsules also contain D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, and pharmaceutical glaze; the 20 mg capsule also contains Black Iron Oxide, FD&C Blue #2 Aluminum Lake, and FD&C Red #40 Aluminum Lake; the 40 mg capsule also contains Red Iron Oxide, shellac, and Yellow Iron Oxide."
},
{
"NDCCode": "63187-637-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (63187-637-90) ",
"NDC11Code": "63187-0637-90",
"ProductNDC": "63187-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202446",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2022-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, lactose (monohydrate), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, iron oxide red, talc, titanium dioxide and xanthan gum."
},
{
"NDCCode": "63304-637-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (63304-637-90)",
"NDC11Code": "63304-0637-90",
"ProductNDC": "63304-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ganciclovir",
"NonProprietaryName": "Ganciclovir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20030827",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076457",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "GANCICLOVIR",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ganciclovir capsules are indicated for the prevention of CMV disease in solid organ transplant recipients and in individuals with advanced HIV infection at risk for developing CMV disease. Ganciclovir capsules are also indicated as an alternative to the intravenous formulation for maintenance treatment of CMV retinitis in immunocompromised patients, including patients with AIDS, in whom retinitis is stable following appropriate induction therapy and for whom the risk of more rapid progression is balanced by the benefit associated with avoiding daily IV infusions (see CLINICAL TRIALS). SAFETY AND EFFICACY OF GANCICLOVIR HAVE NOT BEEN ESTABLISHED FOR CONGENITAL OR NEONATAL CMV DISEASE; NOT FOR THE TREATMENT OF ESTABLISHED CMV DISEASE OTHER THAN RETINITIS; NOR FOR USE IN NON-IMMUNOCOMPROMISED INDIVIDUALS. THE SAFETY AND EFFICACY OF GANCICLOVIR CAPSULES HAVE NOT BEEN ESTABLISHED FOR TREATING ANY MANIFESTATION OF CMV DISEASE OTHER THAN MAINTENANCE TREATMENT OF CMV RETINITIS.",
"Description": "Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). Ganciclovir is available as 250 mg and 500 mg capsules. Each capsule contains 250 mg or 500 mg ganciclovir, USP respectively, and inactive ingredients croscarmellose sodium, FD&C blue #2, gelatin, iron oxide black, iron oxide yellow, lecithin, magnesium stearate, microcrystalline cellulose, povidone, shellac, simethicone, and titanium dioxide. Ganciclovir is a white to off-white crystalline powder with a molecular formula of C9H13N504 and a molecular weight of 255.23. The chemical name for ganciclovir is 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine. Ganciclovir is a polar hydrophilic compound with a solubility of 2.6 mg/mL in water at 25° C and an n-octanol/water partition coefficient of 0.022. The pKas for ganciclovir are 2.2 and 9.4. The molecular structure of ganciclovir is. All doses in this insert are specified in terms of ganciclovir."
},
{
"NDCCode": "65162-637-09",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-09) ",
"NDC11Code": "65162-0637-09",
"ProductNDC": "65162-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205119",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160620",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium, USP sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium, USP is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet, USP contains 45.1 mg or 22.56 mg of pantoprazole sodium, USP sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: ammonium hydroxide, crospovidone, hydroxyl propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, mannitol, methacrylic acid copolymer dispersion, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, shellac, sodium carbonate, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP (40 mg and 20 mg) complies with USP dissolution test 2."
},
{
"NDCCode": "65841-637-16",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-637-16) ",
"NDC11Code": "65841-0637-16",
"ProductNDC": "65841-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078239",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130107",
"SamplePackage": "N"
},
{
"NDCCode": "65862-637-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (65862-637-90) ",
"NDC11Code": "65862-0637-90",
"ProductNDC": "65862-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irbesartan",
"NonProprietaryName": "Irbesartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203081",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "IRBESARTAN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120927",
"SamplePackage": "N",
"IndicationAndUsage": "Irbesartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. (1.2) .",
"Description": "Irbesartan is an angiotensin II receptor (AT1 subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its molecular formula is C25H28N6O, and the structural formula: Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water.Irbesartan tablets, USP are available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of irbesartan USP. Inactive ingredients include: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, microcrystalline cellulose, polysorbate, sodium starch glycolate, sodium stearyl fumarate, and talc."
},
{
"NDCCode": "68180-637-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (68180-637-09) ",
"NDC11Code": "68180-0637-09",
"ProductNDC": "68180-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204991",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200924",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium is indicated: 1 To reduce the risk of.Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is1H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-calcium salt (2:1), trihydrate [R-(R*,R*)]-. The empirical formula of atorvastatin calcium is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4.5 and below. Atorvastatin calcium is very slightly soluble in distilled water and pH 7.5 phosphate buffer; sparingly soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain 10, 20, 40, or 80 mg of atorvastatin and the following inactive ingredients: anhydrous lactose, calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, Opadry AMB OY-B-28920 White (lecithin, polyvinyl alcohol, talc, titanium dioxide, xanthan gum) and sodium lauryl sulphate. Atorvastatin calcium tablets, USP meet USP Dissolution Test 6."
},
{
"NDCCode": "71205-637-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71205-637-90) ",
"NDC11Code": "71205-0637-90",
"ProductNDC": "71205-637",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206531",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220203",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "76420-637-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (76420-637-90) ",
"NDC11Code": "76420-0637-90",
"ProductNDC": "76420-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212199",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "275",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231018",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis.",
"Description": "Naproxen sodium tablets, USP are nonsteroidal anti-inflammatory drugs and available as white capsule-shape tablets, containing 275 mg or 550 mg of naproxen sodium for oral administration. Naproxen sodium is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen sodium is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt. Naproxen sodium has a molecular weight of 252.25 and a molecular formula of C 14H 13NaO 3. It has the following structural formula:. Naproxen is white to creamy crystalline powder. It is soluble in water and methanol, practically insoluble in chloroform, toluene and acetone, sparingly soluble in alcohol. Each naproxen sodium tablet, USP contains the following inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, talc, and titanium dioxide."
},
{
"NDCCode": "50742-123-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50742-123-90)",
"NDC11Code": "50742-0123-90",
"ProductNDC": "50742-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finasteride",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090121",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50742-151-90",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (50742-151-90) ",
"NDC11Code": "50742-0151-90",
"ProductNDC": "50742-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211368",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190311",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets, USP a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2- pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium, USP is a white to almost white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and practically insoluble in n-hexane. Pantoprazole sodium, USP is supplied as delayed release tablets, available in single strength, 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP). Pantoprazole sodium delayed-release tablets, USP contain the following inactive ingredients: lactose monohydrate, hypromellose, crospovidone, talc, calcium stearate, povidone, propylene glycol, titanium dioxide, ferric oxide yellow, methacrylic acid and ethyl acrylate copolymer, and triethyl citrate. The tablets are imprinted with black ink containing iron oxide black, propylene glycol, and hypromellose. Pantoprazole sodium delayed-release tablets USP, 40 mg complies with USP dissolution test 3."
},
{
"NDCCode": "50742-152-90",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50742-152-90) > 90 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "50742-0152-90",
"ProductNDC": "50742-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Modafinil",
"NonProprietaryName": "Modafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140401",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078963",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "MODAFINIL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140401",
"EndMarketingDatePackage": "20190831",
"SamplePackage": "N"
},
{
"NDCCode": "50742-153-90",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50742-153-90) > 90 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "50742-0153-90",
"ProductNDC": "50742-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Modafinil",
"NonProprietaryName": "Modafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140401",
"EndMarketingDate": "20200131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078963",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "MODAFINIL",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140401",
"EndMarketingDatePackage": "20200131",
"SamplePackage": "N"
},
{
"NDCCode": "50742-154-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50742-154-90) ",
"NDC11Code": "50742-0154-90",
"ProductNDC": "50742-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140716",
"EndMarketingDate": "20220228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090564",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140716",
"EndMarketingDatePackage": "20220228",
"SamplePackage": "N"
},
{
"NDCCode": "50742-155-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50742-155-90) ",
"NDC11Code": "50742-0155-90",
"ProductNDC": "50742-155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140716",
"EndMarketingDate": "20220228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090564",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140716",
"EndMarketingDatePackage": "20220228",
"SamplePackage": "N"
},
{
"NDCCode": "50742-156-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50742-156-90) ",
"NDC11Code": "50742-0156-90",
"ProductNDC": "50742-156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140716",
"EndMarketingDate": "20220228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090564",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140716",
"EndMarketingDatePackage": "20220228",
"SamplePackage": "N"
},
{
"NDCCode": "50742-193-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (50742-193-90) ",
"NDC11Code": "50742-0193-90",
"ProductNDC": "50742-193",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolcapone",
"NonProprietaryName": "Tolcapone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208937",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "TOLCAPONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2019-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180821",
"SamplePackage": "N",
"IndicationAndUsage": "Tolcapone tablets, USP is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Because of the risk of potentially fatal, acute fulminant liver failure, tolcapone tablets, USP should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies. Because of the risk of liver injury and because tolcapone tablets, USP, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment, should be withdrawn from tolcapone tablets, USP. The effectiveness of tolcapone tablets, USP was demonstrated in randomized controlled trials in patients receiving concomitant levodopa therapy with carbidopa or another aromatic amino acid decarboxylase inhibitor who experienced end of dose wearing-off phenomena as well as in patients who did not experience such phenomena (see CLINICAL PHARMACOLOGY: Clinical Studies).",
"Description": "Tolcapone tablets, USP is available as tablets containing 100 mg tolcapone, USP. Tolcapone, an inhibitor of catechol-O-methyltransferase (COMT), is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy. It is a yellow, non-hygroscopic, fine powder or fine powder with lumps with a relative molecular mass of 273.24. The chemical name of tolcapone is 3,4-dihydroxy-4'-methyl-5-nitrobenzophenone. Its empirical formula is C14H11NO5 and its structural formula is. Inactive ingredients: Core: lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, povidone, talc and magnesium stearate.Film coating: hydroxypropyl methylcellulose, titanium dioxide, talc, ethyl cellulose, triacetin,and sodium lauryl sulfate, with the following dye system: yellow iron oxide."
},
{
"NDCCode": "50742-234-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-234-90) ",
"NDC11Code": "50742-0234-90",
"ProductNDC": "50742-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204853",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170508",
"SamplePackage": "N"
},
{
"NDCCode": "50742-246-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (50742-246-90) ",
"NDC11Code": "50742-0246-90",
"ProductNDC": "50742-246",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Dinitrate And Hydralazine Hydrochloride",
"NonProprietaryName": "Isosorbide Dinitrate And Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215586",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE",
"StrengthNumber": "37.5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC], Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220412",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide dinitrate and hydralazine hydrochloride tablets is a combination of isosorbide dinitrate, a nitrate vasodilator, and hydralazine hydrochloride, an arteriolar vasodilator, indicated for:. ● the treatment of heart failure as an adjunct therapy to standard therapy in self-identified black patients to improve survival, prolong time to hospitalization for heart failure and to improve patient-reported functional status (1.1). Limitations of use:. ● There is little experience in patients with NYHA class IV heart failure (1.2).",
"Description": "Isosorbide dinitrate and hydralazine hydrochloride tablets is a fixed-dose combination of isosorbide dinitrate, a vasodilator with effects on both arteries and veins, and hydralazine hydrochloride, a predominantly arterial vasodilator. Isosorbide dinitrate is described chemically as 1,4:3,6-dianhydro-D-glucitol dinitrate and its structural formula is. Isosorbide dinitrate is a white to off-white, crystalline powder with the empirical formula C6H8N2O8 and a molecular weight of 236.14. It is freely soluble in organic solvents such as alcohol, chloroform and ether, but is only sparingly soluble in water. Hydralazine hydrochloride is described chemically as 1-hydrazinophthalazine monohydrochloride, and its structural formula is. Hydralazine hydrochloride is a white to off-white, crystalline powder with the empirical formula C8H8N4HCl and a molecular weight of 196.64. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. Each isosorbide dinitrate and hydralazine hydrochloride tablet for oral administration contains 20 mg of isosorbide dinitrate and 37.5 mg of hydralazine hydrochloride. The inactive ingredients in isosorbide dinitrate and hydralazine hydrochloride tablets include: microcrystalline cellulose, anhydrous lactose, hypromellose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, mannitol, FD&C yellow #6, stearic acid, triacetin, FDC red #40 and FDC blue #1."
},
{
"NDCCode": "50742-248-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-248-90) ",
"NDC11Code": "50742-0248-90",
"ProductNDC": "50742-248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208783",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190614",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: hypromellose, sucrose, starch (maize), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, talc, hydroxypropylcellulose, ammonio methacrylate copolymer, ethylcellulose, diethyl phthalate, magnesium stearate, titanium dioxide, polydextrose, triacetin, Macrogol/PEG, gelatin, sodium lauryl sulphate, shellac, potassium hydroxide, black iron oxide, FD&C Blue #1(180 mg, 240 mg, 300 mg and 360 mg) and FD&C Yellow#6 (180 mg and 240 mg). For oral administration. Product meets USP dissolution test 24."
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{
"NDCCode": "50742-249-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-249-90) ",
"NDC11Code": "50742-0249-90",
"ProductNDC": "50742-249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Ingenus Pharmaceuticals, LLC",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
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"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: hypromellose, sucrose, starch (maize), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, talc, hydroxypropylcellulose, ammonio methacrylate copolymer, ethylcellulose, diethyl phthalate, magnesium stearate, titanium dioxide, polydextrose, triacetin, Macrogol/PEG, gelatin, sodium lauryl sulphate, shellac, potassium hydroxide, black iron oxide, FD&C Blue #1(180 mg, 240 mg, 300 mg and 360 mg) and FD&C Yellow#6 (180 mg and 240 mg). For oral administration. Product meets USP dissolution test 24."
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{
"NDCCode": "50742-250-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-250-90) ",
"NDC11Code": "50742-0250-90",
"ProductNDC": "50742-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: hypromellose, sucrose, starch (maize), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, talc, hydroxypropylcellulose, ammonio methacrylate copolymer, ethylcellulose, diethyl phthalate, magnesium stearate, titanium dioxide, polydextrose, triacetin, Macrogol/PEG, gelatin, sodium lauryl sulphate, shellac, potassium hydroxide, black iron oxide, FD&C Blue #1(180 mg, 240 mg, 300 mg and 360 mg) and FD&C Yellow#6 (180 mg and 240 mg). For oral administration. Product meets USP dissolution test 24."
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{
"NDCCode": "50742-251-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-90) ",
"NDC11Code": "50742-0251-90",
"ProductNDC": "50742-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
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"LabelerName": "Ingenus Pharmaceuticals, LLC",
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"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: hypromellose, sucrose, starch (maize), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, talc, hydroxypropylcellulose, ammonio methacrylate copolymer, ethylcellulose, diethyl phthalate, magnesium stearate, titanium dioxide, polydextrose, triacetin, Macrogol/PEG, gelatin, sodium lauryl sulphate, shellac, potassium hydroxide, black iron oxide, FD&C Blue #1(180 mg, 240 mg, 300 mg and 360 mg) and FD&C Yellow#6 (180 mg and 240 mg). For oral administration. Product meets USP dissolution test 24."
},
{
"NDCCode": "50742-252-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-252-90) ",
"NDC11Code": "50742-0252-90",
"ProductNDC": "50742-252",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
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"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: hypromellose, sucrose, starch (maize), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, talc, hydroxypropylcellulose, ammonio methacrylate copolymer, ethylcellulose, diethyl phthalate, magnesium stearate, titanium dioxide, polydextrose, triacetin, Macrogol/PEG, gelatin, sodium lauryl sulphate, shellac, potassium hydroxide, black iron oxide, FD&C Blue #1(180 mg, 240 mg, 300 mg and 360 mg) and FD&C Yellow#6 (180 mg and 240 mg). For oral administration. Product meets USP dissolution test 24."
},
{
"NDCCode": "50742-285-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (50742-285-90) ",
"NDC11Code": "50742-0285-90",
"ProductNDC": "50742-285",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hemiclor",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250317",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218647",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
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"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
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"IndicationAndUsage": "HEMICLOR is a thiazide-like diuretic indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1).",
"Description": "HEMICLOR (chlorthalidone) is an antihypertensive/diuretic supplied as 12.5 mg tablets for oral use. Chlorthalidone is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double ring system is incorporated in its structure. It is a racemic mixture of 2-chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl) benzenesulfonamide, with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular Weight: 338.8 g/mol. Chlorthalidone is practically insoluble in water, soluble in acetone and in methanol, slightly soluble in 96% ethanol, practically insoluble in dichloromethane. It dissolves in diluted solutions of alkali hydroxides. Each HEMICLOR tablet contains the following inactive ingredients: calcium stearate, colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate."
}
]
}
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<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (light yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients: The following are common in all 5 tablet strengths: microcrystalline cellulose, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Additional inactive ingredients include: 50 mg - polyvinyl alcohol, talc, iron oxide yellow, iron oxide red, iron oxide black, lecithin (soya);150 mg - polydextrose and triacetin; 200 mg - polyvinyl alcohol, talc, lecithin (soya), D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake; 300 mg - polyvinyl alcohol, talc, lecithin (soya), iron oxide yellow and iron oxide black; 400 mg - polydextrose, and triacetin. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. Meets USP dissolution test 6.</Description>
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<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (light yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients: The following are common in all 5 tablet strengths: microcrystalline cellulose, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Additional inactive ingredients include: 50 mg - polyvinyl alcohol, talc, iron oxide yellow, iron oxide red, iron oxide black, lecithin (soya);150 mg - polydextrose and triacetin; 200 mg - polyvinyl alcohol, talc, lecithin (soya), D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake; 300 mg - polyvinyl alcohol, talc, lecithin (soya), iron oxide yellow and iron oxide black; 400 mg - polydextrose, and triacetin. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. Meets USP dissolution test 6.</Description>
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<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine extended-release tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (light yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients: The following are common in all 5 tablet strengths: microcrystalline cellulose, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Additional inactive ingredients include: 50 mg - polyvinyl alcohol, talc, iron oxide yellow, iron oxide red, iron oxide black, lecithin (soya);150 mg - polydextrose and triacetin; 200 mg - polyvinyl alcohol, talc, lecithin (soya), D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake; 300 mg - polyvinyl alcohol, talc, lecithin (soya), iron oxide yellow and iron oxide black; 400 mg - polydextrose, and triacetin. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. Meets USP dissolution test 6.</Description>
</NDC>
<NDC>
<NDCCode>34908-637-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-637-90) </PackageDescription>
<NDC11Code>34908-0637-90</NDC11Code>
<ProductNDC>34908-637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208947</ApplicationNumber>
<LabelerName>Novast Laboratories, Ltd.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43353-637-60</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (43353-637-60) </PackageDescription>
<NDC11Code>43353-0637-60</NDC11Code>
<ProductNDC>43353-637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075049</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, Inc.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fluoxetine is a selective serotonin reuptake inhibitor indicated for: 1 Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1), 2 Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2), 3 Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3), 4 Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).</IndicationAndUsage>
<Description>Fluoxetine capsules are a psychotropic drug for oral administration. They are also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). They are designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and have the empirical formula of C17H18F3NOHCl. The molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule, for oral administration, contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine. The inactive ingredients are: corn starch, gelatin, magnesium stearate, pregelatinized starch, propylene glycol, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. The 10 and 20 mg capsules also contain D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, and pharmaceutical glaze; the 20 mg capsule also contains Black Iron Oxide, FD&C Blue #2 Aluminum Lake, and FD&C Red #40 Aluminum Lake; the 40 mg capsule also contains Red Iron Oxide, shellac, and Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>63187-637-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63187-637-90) </PackageDescription>
<NDC11Code>63187-0637-90</NDC11Code>
<ProductNDC>63187-637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202446</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, lactose (monohydrate), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, iron oxide red, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>63304-637-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (63304-637-90)</PackageDescription>
<NDC11Code>63304-0637-90</NDC11Code>
<ProductNDC>63304-637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ganciclovir</ProprietaryName>
<NonProprietaryName>Ganciclovir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030827</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076457</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GANCICLOVIR</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ganciclovir capsules are indicated for the prevention of CMV disease in solid organ transplant recipients and in individuals with advanced HIV infection at risk for developing CMV disease. Ganciclovir capsules are also indicated as an alternative to the intravenous formulation for maintenance treatment of CMV retinitis in immunocompromised patients, including patients with AIDS, in whom retinitis is stable following appropriate induction therapy and for whom the risk of more rapid progression is balanced by the benefit associated with avoiding daily IV infusions (see CLINICAL TRIALS). SAFETY AND EFFICACY OF GANCICLOVIR HAVE NOT BEEN ESTABLISHED FOR CONGENITAL OR NEONATAL CMV DISEASE; NOT FOR THE TREATMENT OF ESTABLISHED CMV DISEASE OTHER THAN RETINITIS; NOR FOR USE IN NON-IMMUNOCOMPROMISED INDIVIDUALS. THE SAFETY AND EFFICACY OF GANCICLOVIR CAPSULES HAVE NOT BEEN ESTABLISHED FOR TREATING ANY MANIFESTATION OF CMV DISEASE OTHER THAN MAINTENANCE TREATMENT OF CMV RETINITIS.</IndicationAndUsage>
<Description>Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). Ganciclovir is available as 250 mg and 500 mg capsules. Each capsule contains 250 mg or 500 mg ganciclovir, USP respectively, and inactive ingredients croscarmellose sodium, FD&C blue #2, gelatin, iron oxide black, iron oxide yellow, lecithin, magnesium stearate, microcrystalline cellulose, povidone, shellac, simethicone, and titanium dioxide. Ganciclovir is a white to off-white crystalline powder with a molecular formula of C9H13N504 and a molecular weight of 255.23. The chemical name for ganciclovir is 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine. Ganciclovir is a polar hydrophilic compound with a solubility of 2.6 mg/mL in water at 25° C and an n-octanol/water partition coefficient of 0.022. The pKas for ganciclovir are 2.2 and 9.4. The molecular structure of ganciclovir is. All doses in this insert are specified in terms of ganciclovir.</Description>
</NDC>
<NDC>
<NDCCode>65162-637-09</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-09) </PackageDescription>
<NDC11Code>65162-0637-09</NDC11Code>
<ProductNDC>65162-637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205119</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium, USP sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium, USP is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet, USP contains 45.1 mg or 22.56 mg of pantoprazole sodium, USP sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: ammonium hydroxide, crospovidone, hydroxyl propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, mannitol, methacrylic acid copolymer dispersion, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, shellac, sodium carbonate, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP (40 mg and 20 mg) complies with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>65841-637-16</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-637-16) </PackageDescription>
<NDC11Code>65841-0637-16</NDC11Code>
<ProductNDC>65841-637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078239</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65862-637-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (65862-637-90) </PackageDescription>
<NDC11Code>65862-0637-90</NDC11Code>
<ProductNDC>65862-637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irbesartan</ProprietaryName>
<NonProprietaryName>Irbesartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120927</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203081</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>IRBESARTAN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Irbesartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. (1.2) .</IndicationAndUsage>
<Description>Irbesartan is an angiotensin II receptor (AT1 subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its molecular formula is C25H28N6O, and the structural formula: Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water.Irbesartan tablets, USP are available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of irbesartan USP. Inactive ingredients include: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, microcrystalline cellulose, polysorbate, sodium starch glycolate, sodium stearyl fumarate, and talc.</Description>
</NDC>
<NDC>
<NDCCode>68180-637-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68180-637-09) </PackageDescription>
<NDC11Code>68180-0637-09</NDC11Code>
<ProductNDC>68180-637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204991</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</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>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200924</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium is indicated: 1 To reduce the risk of.Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is1H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-calcium salt (2:1), trihydrate [R-(R*,R*)]-. The empirical formula of atorvastatin calcium is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4.5 and below. Atorvastatin calcium is very slightly soluble in distilled water and pH 7.5 phosphate buffer; sparingly soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain 10, 20, 40, or 80 mg of atorvastatin and the following inactive ingredients: anhydrous lactose, calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, Opadry AMB OY-B-28920 White (lecithin, polyvinyl alcohol, talc, titanium dioxide, xanthan gum) and sodium lauryl sulphate. Atorvastatin calcium tablets, USP meet USP Dissolution Test 6.</Description>
</NDC>
<NDC>
<NDCCode>71205-637-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71205-637-90) </PackageDescription>
<NDC11Code>71205-0637-90</NDC11Code>
<ProductNDC>71205-637</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206531</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76420-637-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (76420-637-90) </PackageDescription>
<NDC11Code>76420-0637-90</NDC11Code>
<ProductNDC>76420-637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212199</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>275</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis.</IndicationAndUsage>
<Description>Naproxen sodium tablets, USP are nonsteroidal anti-inflammatory drugs and available as white capsule-shape tablets, containing 275 mg or 550 mg of naproxen sodium for oral administration. Naproxen sodium is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen sodium is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt. Naproxen sodium has a molecular weight of 252.25 and a molecular formula of C 14H 13NaO 3. It has the following structural formula:. Naproxen is white to creamy crystalline powder. It is soluble in water and methanol, practically insoluble in chloroform, toluene and acetone, sparingly soluble in alcohol. Each naproxen sodium tablet, USP contains the following inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50742-123-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50742-123-90)</PackageDescription>
<NDC11Code>50742-0123-90</NDC11Code>
<ProductNDC>50742-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finasteride</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090121</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50742-151-90</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (50742-151-90) </PackageDescription>
<NDC11Code>50742-0151-90</NDC11Code>
<ProductNDC>50742-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211368</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets, USP a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2- pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium, USP is a white to almost white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and practically insoluble in n-hexane. Pantoprazole sodium, USP is supplied as delayed release tablets, available in single strength, 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP). Pantoprazole sodium delayed-release tablets, USP contain the following inactive ingredients: lactose monohydrate, hypromellose, crospovidone, talc, calcium stearate, povidone, propylene glycol, titanium dioxide, ferric oxide yellow, methacrylic acid and ethyl acrylate copolymer, and triethyl citrate. The tablets are imprinted with black ink containing iron oxide black, propylene glycol, and hypromellose. Pantoprazole sodium delayed-release tablets USP, 40 mg complies with USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>50742-152-90</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50742-152-90) > 90 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50742-0152-90</NDC11Code>
<ProductNDC>50742-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Modafinil</ProprietaryName>
<NonProprietaryName>Modafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140401</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078963</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MODAFINIL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140401</StartMarketingDatePackage>
<EndMarketingDatePackage>20190831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50742-153-90</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50742-153-90) > 90 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50742-0153-90</NDC11Code>
<ProductNDC>50742-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Modafinil</ProprietaryName>
<NonProprietaryName>Modafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140401</StartMarketingDate>
<EndMarketingDate>20200131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078963</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MODAFINIL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140401</StartMarketingDatePackage>
<EndMarketingDatePackage>20200131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50742-154-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50742-154-90) </PackageDescription>
<NDC11Code>50742-0154-90</NDC11Code>
<ProductNDC>50742-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140716</StartMarketingDate>
<EndMarketingDate>20220228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090564</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140716</StartMarketingDatePackage>
<EndMarketingDatePackage>20220228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50742-155-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50742-155-90) </PackageDescription>
<NDC11Code>50742-0155-90</NDC11Code>
<ProductNDC>50742-155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140716</StartMarketingDate>
<EndMarketingDate>20220228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090564</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140716</StartMarketingDatePackage>
<EndMarketingDatePackage>20220228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50742-156-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50742-156-90) </PackageDescription>
<NDC11Code>50742-0156-90</NDC11Code>
<ProductNDC>50742-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140716</StartMarketingDate>
<EndMarketingDate>20220228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090564</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140716</StartMarketingDatePackage>
<EndMarketingDatePackage>20220228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50742-193-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50742-193-90) </PackageDescription>
<NDC11Code>50742-0193-90</NDC11Code>
<ProductNDC>50742-193</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolcapone</ProprietaryName>
<NonProprietaryName>Tolcapone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180821</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208937</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TOLCAPONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolcapone tablets, USP is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Because of the risk of potentially fatal, acute fulminant liver failure, tolcapone tablets, USP should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies. Because of the risk of liver injury and because tolcapone tablets, USP, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment, should be withdrawn from tolcapone tablets, USP. The effectiveness of tolcapone tablets, USP was demonstrated in randomized controlled trials in patients receiving concomitant levodopa therapy with carbidopa or another aromatic amino acid decarboxylase inhibitor who experienced end of dose wearing-off phenomena as well as in patients who did not experience such phenomena (see CLINICAL PHARMACOLOGY: Clinical Studies).</IndicationAndUsage>
<Description>Tolcapone tablets, USP is available as tablets containing 100 mg tolcapone, USP. Tolcapone, an inhibitor of catechol-O-methyltransferase (COMT), is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy. It is a yellow, non-hygroscopic, fine powder or fine powder with lumps with a relative molecular mass of 273.24. The chemical name of tolcapone is 3,4-dihydroxy-4'-methyl-5-nitrobenzophenone. Its empirical formula is C14H11NO5 and its structural formula is. Inactive ingredients: Core: lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, povidone, talc and magnesium stearate.Film coating: hydroxypropyl methylcellulose, titanium dioxide, talc, ethyl cellulose, triacetin,and sodium lauryl sulfate, with the following dye system: yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>50742-234-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-234-90) </PackageDescription>
<NDC11Code>50742-0234-90</NDC11Code>
<ProductNDC>50742-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204853</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50742-246-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50742-246-90) </PackageDescription>
<NDC11Code>50742-0246-90</NDC11Code>
<ProductNDC>50742-246</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Dinitrate And Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Isosorbide Dinitrate And Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215586</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE</SubstanceName>
<StrengthNumber>37.5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC], Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide dinitrate and hydralazine hydrochloride tablets is a combination of isosorbide dinitrate, a nitrate vasodilator, and hydralazine hydrochloride, an arteriolar vasodilator, indicated for:. ● the treatment of heart failure as an adjunct therapy to standard therapy in self-identified black patients to improve survival, prolong time to hospitalization for heart failure and to improve patient-reported functional status (1.1). Limitations of use:. ● There is little experience in patients with NYHA class IV heart failure (1.2).</IndicationAndUsage>
<Description>Isosorbide dinitrate and hydralazine hydrochloride tablets is a fixed-dose combination of isosorbide dinitrate, a vasodilator with effects on both arteries and veins, and hydralazine hydrochloride, a predominantly arterial vasodilator. Isosorbide dinitrate is described chemically as 1,4:3,6-dianhydro-D-glucitol dinitrate and its structural formula is. Isosorbide dinitrate is a white to off-white, crystalline powder with the empirical formula C6H8N2O8 and a molecular weight of 236.14. It is freely soluble in organic solvents such as alcohol, chloroform and ether, but is only sparingly soluble in water. Hydralazine hydrochloride is described chemically as 1-hydrazinophthalazine monohydrochloride, and its structural formula is. Hydralazine hydrochloride is a white to off-white, crystalline powder with the empirical formula C8H8N4HCl and a molecular weight of 196.64. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. Each isosorbide dinitrate and hydralazine hydrochloride tablet for oral administration contains 20 mg of isosorbide dinitrate and 37.5 mg of hydralazine hydrochloride. The inactive ingredients in isosorbide dinitrate and hydralazine hydrochloride tablets include: microcrystalline cellulose, anhydrous lactose, hypromellose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, mannitol, FD&C yellow #6, stearic acid, triacetin, FDC red #40 and FDC blue #1.</Description>
</NDC>
<NDC>
<NDCCode>50742-248-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-248-90) </PackageDescription>
<NDC11Code>50742-0248-90</NDC11Code>
<ProductNDC>50742-248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208783</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: hypromellose, sucrose, starch (maize), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, talc, hydroxypropylcellulose, ammonio methacrylate copolymer, ethylcellulose, diethyl phthalate, magnesium stearate, titanium dioxide, polydextrose, triacetin, Macrogol/PEG, gelatin, sodium lauryl sulphate, shellac, potassium hydroxide, black iron oxide, FD&C Blue #1(180 mg, 240 mg, 300 mg and 360 mg) and FD&C Yellow#6 (180 mg and 240 mg). For oral administration. Product meets USP dissolution test 24.</Description>
</NDC>
<NDC>
<NDCCode>50742-249-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-249-90) </PackageDescription>
<NDC11Code>50742-0249-90</NDC11Code>
<ProductNDC>50742-249</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208783</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: hypromellose, sucrose, starch (maize), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, talc, hydroxypropylcellulose, ammonio methacrylate copolymer, ethylcellulose, diethyl phthalate, magnesium stearate, titanium dioxide, polydextrose, triacetin, Macrogol/PEG, gelatin, sodium lauryl sulphate, shellac, potassium hydroxide, black iron oxide, FD&C Blue #1(180 mg, 240 mg, 300 mg and 360 mg) and FD&C Yellow#6 (180 mg and 240 mg). For oral administration. Product meets USP dissolution test 24.</Description>
</NDC>
<NDC>
<NDCCode>50742-250-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-250-90) </PackageDescription>
<NDC11Code>50742-0250-90</NDC11Code>
<ProductNDC>50742-250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208783</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: hypromellose, sucrose, starch (maize), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, talc, hydroxypropylcellulose, ammonio methacrylate copolymer, ethylcellulose, diethyl phthalate, magnesium stearate, titanium dioxide, polydextrose, triacetin, Macrogol/PEG, gelatin, sodium lauryl sulphate, shellac, potassium hydroxide, black iron oxide, FD&C Blue #1(180 mg, 240 mg, 300 mg and 360 mg) and FD&C Yellow#6 (180 mg and 240 mg). For oral administration. Product meets USP dissolution test 24.</Description>
</NDC>
<NDC>
<NDCCode>50742-251-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-90) </PackageDescription>
<NDC11Code>50742-0251-90</NDC11Code>
<ProductNDC>50742-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208783</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: hypromellose, sucrose, starch (maize), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, talc, hydroxypropylcellulose, ammonio methacrylate copolymer, ethylcellulose, diethyl phthalate, magnesium stearate, titanium dioxide, polydextrose, triacetin, Macrogol/PEG, gelatin, sodium lauryl sulphate, shellac, potassium hydroxide, black iron oxide, FD&C Blue #1(180 mg, 240 mg, 300 mg and 360 mg) and FD&C Yellow#6 (180 mg and 240 mg). For oral administration. Product meets USP dissolution test 24.</Description>
</NDC>
<NDC>
<NDCCode>50742-252-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-252-90) </PackageDescription>
<NDC11Code>50742-0252-90</NDC11Code>
<ProductNDC>50742-252</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208783</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: hypromellose, sucrose, starch (maize), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, talc, hydroxypropylcellulose, ammonio methacrylate copolymer, ethylcellulose, diethyl phthalate, magnesium stearate, titanium dioxide, polydextrose, triacetin, Macrogol/PEG, gelatin, sodium lauryl sulphate, shellac, potassium hydroxide, black iron oxide, FD&C Blue #1(180 mg, 240 mg, 300 mg and 360 mg) and FD&C Yellow#6 (180 mg and 240 mg). For oral administration. Product meets USP dissolution test 24.</Description>
</NDC>
<NDC>
<NDCCode>50742-285-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50742-285-90) </PackageDescription>
<NDC11Code>50742-0285-90</NDC11Code>
<ProductNDC>50742-285</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hemiclor</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250317</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218647</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HEMICLOR is a thiazide-like diuretic indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1).</IndicationAndUsage>
<Description>HEMICLOR (chlorthalidone) is an antihypertensive/diuretic supplied as 12.5 mg tablets for oral use. Chlorthalidone is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double ring system is incorporated in its structure. It is a racemic mixture of 2-chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl) benzenesulfonamide, with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular Weight: 338.8 g/mol. Chlorthalidone is practically insoluble in water, soluble in acetone and in methanol, slightly soluble in 96% ethanol, practically insoluble in dichloromethane. It dissolves in diluted solutions of alkali hydroxides. Each HEMICLOR tablet contains the following inactive ingredients: calcium stearate, colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
</NDCList>