{
"NDC": [
{
"NDCCode": "67877-730-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (67877-730-90) ",
"NDC11Code": "67877-0730-90",
"ProductNDC": "67877-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roflumilast",
"NonProprietaryName": "Roflumilast",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212490",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "ROFLUMILAST",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250314",
"SamplePackage": "N",
"IndicationAndUsage": "Roflumilast tablets is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of UseRoflumilast tablets is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.",
"Description": "The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is: The drug substance is a white or practically white crystalline powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Roflumilast tablets is supplied as white to off-white, round shaped, uncoated tablets debossed with “R” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg and 500 mcg of roflumilast. Each tablet of roflumilast tablets for oral administration contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose, and magnesium stearate."
},
{
"NDCCode": "67877-730-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (67877-730-05) ",
"NDC11Code": "67877-0730-05",
"ProductNDC": "67877-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roflumilast",
"NonProprietaryName": "Roflumilast",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212490",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "ROFLUMILAST",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250314",
"SamplePackage": "N",
"IndicationAndUsage": "Roflumilast tablets is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of UseRoflumilast tablets is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.",
"Description": "The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is: The drug substance is a white or practically white crystalline powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Roflumilast tablets is supplied as white to off-white, round shaped, uncoated tablets debossed with “R” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg and 500 mcg of roflumilast. Each tablet of roflumilast tablets for oral administration contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose, and magnesium stearate."
},
{
"NDCCode": "67877-730-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (67877-730-30) ",
"NDC11Code": "67877-0730-30",
"ProductNDC": "67877-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roflumilast",
"NonProprietaryName": "Roflumilast",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212490",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "ROFLUMILAST",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250314",
"SamplePackage": "N",
"IndicationAndUsage": "Roflumilast tablets is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of UseRoflumilast tablets is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.",
"Description": "The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is: The drug substance is a white or practically white crystalline powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Roflumilast tablets is supplied as white to off-white, round shaped, uncoated tablets debossed with “R” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg and 500 mcg of roflumilast. Each tablet of roflumilast tablets for oral administration contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose, and magnesium stearate."
},
{
"NDCCode": "67877-730-87",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (67877-730-87) / 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "67877-0730-87",
"ProductNDC": "67877-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roflumilast",
"NonProprietaryName": "Roflumilast",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212490",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "ROFLUMILAST",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250314",
"SamplePackage": "N",
"IndicationAndUsage": "Roflumilast tablets is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of UseRoflumilast tablets is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.",
"Description": "The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is: The drug substance is a white or practically white crystalline powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Roflumilast tablets is supplied as white to off-white, round shaped, uncoated tablets debossed with “R” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg and 500 mcg of roflumilast. Each tablet of roflumilast tablets for oral administration contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose, and magnesium stearate."
},
{
"NDCCode": "67877-730-93",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (67877-730-93) / 7 TABLET in 1 BLISTER PACK (67877-730-32) ",
"NDC11Code": "67877-0730-93",
"ProductNDC": "67877-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roflumilast",
"NonProprietaryName": "Roflumilast",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212490",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "ROFLUMILAST",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250314",
"SamplePackage": "N",
"IndicationAndUsage": "Roflumilast tablets is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of UseRoflumilast tablets is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.",
"Description": "The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is: The drug substance is a white or practically white crystalline powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Roflumilast tablets is supplied as white to off-white, round shaped, uncoated tablets debossed with “R” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg and 500 mcg of roflumilast. Each tablet of roflumilast tablets for oral administration contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose, and magnesium stearate."
},
{
"NDCCode": "17224-730-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (17224-730-90) ",
"NDC11Code": "17224-0730-90",
"ProductNDC": "17224-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diethylpropion Hydrochloride",
"NonProprietaryName": "Diethylpropion Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201212",
"LabelerName": "Calvin Scott & Co., Inc.",
"SubstanceName": "DIETHYLPROPION HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101227",
"SamplePackage": "N",
"IndicationAndUsage": "Diethylpropion hydrochloride is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of BMI based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds divided by 2.2 = kg; inches x 0.0254 = meters. The usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below. Diethylpropion hydrochloride is indicated for use as monotherapy only.",
"Description": "Diethylpropion hydrochloride is available for oral administration in immediate-release tablets containing 25 mg diethylpropion hydrochloride. The inactive ingredients in each immediate-release tablet are: crospovidone, lactose anhydrous, magnesium stearate, starch pregelatinized and tartaric acid. Diethylpropion hydrochloride is a sympathomimetic agent. The chemical name for diethylpropion hydrochloride is 1-phenyl-2-diethylamino-1-propanone hydrochloride. Its chemical structure is."
},
{
"NDCCode": "23155-730-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (23155-730-09) ",
"NDC11Code": "23155-0730-09",
"ProductNDC": "23155-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nadolol",
"NonProprietaryName": "Nadolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074229",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "NADOLOL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210226",
"SamplePackage": "N"
},
{
"NDCCode": "31722-730-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (31722-730-90) ",
"NDC11Code": "31722-0730-90",
"ProductNDC": "31722-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irbesartan",
"NonProprietaryName": "Irbesartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202910",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "IRBESARTAN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120927",
"SamplePackage": "N",
"IndicationAndUsage": "Irbesartan tablet is an angiotensin II receptor blocker (ARB) indicated for: 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) 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 (AT 1subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3 -[p-(o-1 H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4] non-1-en-4-one. Its molecular formula is C 25H 28N 6O, and the structural formula:. Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.53. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in ethanol and methylene chloride and practically insoluble in water. Irbesartan is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of irbesartan USP. Inactive ingredients include: calcium stearate, carboxy methyl cellulose calcium, colloidal silicon dioxide, microcrystalline cellulose and povidone."
},
{
"NDCCode": "35356-730-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (35356-730-90)",
"NDC11Code": "35356-0730-90",
"ProductNDC": "35356-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075786",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "42291-730-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42291-730-90)",
"NDC11Code": "42291-0730-90",
"ProductNDC": "42291-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078380",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-08",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43063-730-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-730-90) ",
"NDC11Code": "43063-0730-90",
"ProductNDC": "43063-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090682",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190208",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients(1.1) : 1 Cold Sores (Herpes Labialis), 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-1-infected patientsReduction of transmission, 3 Herpes Zoster .",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 556 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "55289-730-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-730-90) ",
"NDC11Code": "55289-0730-90",
"ProductNDC": "55289-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040218",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100413",
"SamplePackage": "N"
},
{
"NDCCode": "55700-730-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (55700-730-90) ",
"NDC11Code": "55700-0730-90",
"ProductNDC": "55700-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203769",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190315",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains Hypromellose, polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide."
},
{
"NDCCode": "61786-730-19",
"PackageDescription": "90 TABLET in 1 BOTTLE (61786-730-19) ",
"NDC11Code": "61786-0730-19",
"ProductNDC": "61786-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074550",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160607",
"SamplePackage": "N"
},
{
"NDCCode": "61919-730-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (61919-730-90) ",
"NDC11Code": "61919-0730-90",
"ProductNDC": "61919-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078332",
"LabelerName": "DIRECT RX",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190422",
"SamplePackage": "N",
"IndicationAndUsage": "1.2 Left Ventricular Dysfunction Following Myocardial Infarction. Carvedilol Tablet is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies ( 14.2)]. 1.3 Hypertension. Carvedilol Tablet is indicated for the management of essential hypertension [see Clinical Studies ( 14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions ( 7.2)].",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol Tablet is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5)."
},
{
"NDCCode": "64764-730-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (64764-730-90) ",
"NDC11Code": "64764-0730-90",
"ProductNDC": "64764-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trintellix",
"NonProprietaryName": "Vortioxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204447",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "VORTIOXETINE HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131002",
"SamplePackage": "N",
"IndicationAndUsage": "TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg)."
},
{
"NDCCode": "65841-730-16",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (65841-730-16) ",
"NDC11Code": "65841-0730-16",
"ProductNDC": "65841-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078243",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101004",
"SamplePackage": "N"
},
{
"NDCCode": "66267-730-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (66267-730-90) ",
"NDC11Code": "66267-0730-90",
"ProductNDC": "66267-730",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Senna",
"ProprietaryNameSuffix": "Standardized Senna Concentrate 8.6 Mg Sennosides Each",
"NonProprietaryName": "Sennosides",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060327",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "SENNOSIDES",
"StrengthNumber": "8.6",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181019",
"SamplePackage": "N"
},
{
"NDCCode": "68180-730-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (68180-730-09) ",
"NDC11Code": "68180-0730-09",
"ProductNDC": "68180-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205587",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170731",
"SamplePackage": "N",
"IndicationAndUsage": "Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca's CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca's marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to light yellow amorphous powder that is sparingly soluble in water and methanol, and soluble in N, N-Dimethylformamide. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin calcium tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, hypromellose, iron oxide red (in 10 mg, 20 mg and 40 mg), iron oxide yellow (in 5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
},
{
"NDCCode": "76282-730-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (76282-730-90) ",
"NDC11Code": "76282-0730-90",
"ProductNDC": "76282-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076102",
"LabelerName": "Exelan Pharmaceuticals, Inc",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230407",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol.Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – anhydrous lactose, magnesium stearate. 5 mg, 10 mg, 20 mg and 30 mg tablets – anhydrous lactose, magnesium stearate, iron oxide red. 40 mg tablets – anhydrous lactose, magnesium stearate, iron oxide yellow."
},
{
"NDCCode": "67877-064-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-064-90) ",
"NDC11Code": "67877-0064-90",
"ProductNDC": "67877-064",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fesoterodine Fumarate",
"NonProprietaryName": "Fesoterodine Fumarate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204827",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "FESOTERODINE FUMARATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220609",
"SamplePackage": "N",
"IndicationAndUsage": "Fesoterodine fumarate extended-release tablets are indicated for the treatment of: 1 Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1).",
"Description": "Fesoterodine fumarate extended-release tablets contains fesoterodine fumarate. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1 phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C30H41NO7 and its molecular weight is 527.66. The structural formula is:. The asterisk (*) indicates the chiral carbon. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each fesoterodine fumarate extended-release tablets contains either 4 mg or 8mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, FD&C Blue #2/Indigo carmine aluminum lake, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
},
{
"NDCCode": "67877-068-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-068-90) ",
"NDC11Code": "67877-0068-90",
"ProductNDC": "67877-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fesoterodine Fumarate",
"NonProprietaryName": "Fesoterodine Fumarate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204827",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "FESOTERODINE FUMARATE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220609",
"SamplePackage": "N",
"IndicationAndUsage": "Fesoterodine fumarate extended-release tablets are indicated for the treatment of: 1 Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1).",
"Description": "Fesoterodine fumarate extended-release tablets contains fesoterodine fumarate. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1 phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C30H41NO7 and its molecular weight is 527.66. The structural formula is:. The asterisk (*) indicates the chiral carbon. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each fesoterodine fumarate extended-release tablets contains either 4 mg or 8mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, FD&C Blue #2/Indigo carmine aluminum lake, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
},
{
"NDCCode": "67877-197-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (67877-197-90) ",
"NDC11Code": "67877-0197-90",
"ProductNDC": "67877-197",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078925",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2024-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101020",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension (1.1): 1 Amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl(±)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate."
},
{
"NDCCode": "67877-198-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (67877-198-90) ",
"NDC11Code": "67877-0198-90",
"ProductNDC": "67877-198",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078925",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2024-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101020",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension (1.1): 1 Amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl(±)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate."
},
{
"NDCCode": "67877-199-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (67877-199-90) ",
"NDC11Code": "67877-0199-90",
"ProductNDC": "67877-199",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078925",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2024-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101020",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension (1.1): 1 Amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl(±)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate."
},
{
"NDCCode": "67877-256-90",
"PackageDescription": "2 BOTTLE in 1 CARTON (67877-256-90) / 45 TABLET, CHEWABLE in 1 BOTTLE (67877-256-45) ",
"NDC11Code": "67877-0256-90",
"ProductNDC": "67877-256",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lanthanum Carbonate",
"NonProprietaryName": "Lanthanum Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202329",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "LANTHANUM CARBONATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250510",
"SamplePackage": "N",
"IndicationAndUsage": "Lanthanum carbonate is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.",
"Description": "Lanthanum carbonate chewable tablet contains lanthanum carbonate with molecular formula La2(CO3)3 xH2O (where x=8 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate octahydrate is insoluble in water and soluble in acids. The molecular weight of lanthanum carbonate octahydrate is 601.95 g/mol. Each white to off-white, round flat with a beveled edge chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: maltitol, crospovidone and sodium stearyl fumarate. The chemical structure of lanthanum carbonate octahydrate is."
},
{
"NDCCode": "67877-257-90",
"PackageDescription": "6 BOTTLE in 1 CARTON (67877-257-90) / 15 TABLET, CHEWABLE in 1 BOTTLE (67877-257-15) ",
"NDC11Code": "67877-0257-90",
"ProductNDC": "67877-257",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lanthanum Carbonate",
"NonProprietaryName": "Lanthanum Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202329",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "LANTHANUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250510",
"SamplePackage": "N",
"IndicationAndUsage": "Lanthanum carbonate is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.",
"Description": "Lanthanum carbonate chewable tablet contains lanthanum carbonate with molecular formula La2(CO3)3 xH2O (where x=8 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate octahydrate is insoluble in water and soluble in acids. The molecular weight of lanthanum carbonate octahydrate is 601.95 g/mol. Each white to off-white, round flat with a beveled edge chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: maltitol, crospovidone and sodium stearyl fumarate. The chemical structure of lanthanum carbonate octahydrate is."
},
{
"NDCCode": "67877-258-90",
"PackageDescription": "9 BOTTLE in 1 CARTON (67877-258-90) / 10 TABLET, CHEWABLE in 1 BOTTLE (67877-258-11) ",
"NDC11Code": "67877-0258-90",
"ProductNDC": "67877-258",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lanthanum Carbonate",
"NonProprietaryName": "Lanthanum Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202329",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "LANTHANUM CARBONATE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250510",
"SamplePackage": "N",
"IndicationAndUsage": "Lanthanum carbonate is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.",
"Description": "Lanthanum carbonate chewable tablet contains lanthanum carbonate with molecular formula La2(CO3)3 xH2O (where x=8 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate octahydrate is insoluble in water and soluble in acids. The molecular weight of lanthanum carbonate octahydrate is 601.95 g/mol. Each white to off-white, round flat with a beveled edge chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: maltitol, crospovidone and sodium stearyl fumarate. The chemical structure of lanthanum carbonate octahydrate is."
},
{
"NDCCode": "67877-263-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-263-90) ",
"NDC11Code": "67877-0263-90",
"ProductNDC": "67877-263",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203197",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120501",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water.Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water."
},
{
"NDCCode": "67877-264-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-90) ",
"NDC11Code": "67877-0264-90",
"ProductNDC": "67877-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203197",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120501",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water.Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>67877-730-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (67877-730-90) </PackageDescription>
<NDC11Code>67877-0730-90</NDC11Code>
<ProductNDC>67877-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roflumilast</ProprietaryName>
<NonProprietaryName>Roflumilast</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212490</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>ROFLUMILAST</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Roflumilast tablets is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of UseRoflumilast tablets is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.</IndicationAndUsage>
<Description>The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is: The drug substance is a white or practically white crystalline powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Roflumilast tablets is supplied as white to off-white, round shaped, uncoated tablets debossed with “R” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg and 500 mcg of roflumilast. Each tablet of roflumilast tablets for oral administration contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>67877-730-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (67877-730-05) </PackageDescription>
<NDC11Code>67877-0730-05</NDC11Code>
<ProductNDC>67877-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roflumilast</ProprietaryName>
<NonProprietaryName>Roflumilast</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212490</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>ROFLUMILAST</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Roflumilast tablets is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of UseRoflumilast tablets is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.</IndicationAndUsage>
<Description>The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is: The drug substance is a white or practically white crystalline powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Roflumilast tablets is supplied as white to off-white, round shaped, uncoated tablets debossed with “R” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg and 500 mcg of roflumilast. Each tablet of roflumilast tablets for oral administration contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>67877-730-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (67877-730-30) </PackageDescription>
<NDC11Code>67877-0730-30</NDC11Code>
<ProductNDC>67877-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roflumilast</ProprietaryName>
<NonProprietaryName>Roflumilast</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212490</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>ROFLUMILAST</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Roflumilast tablets is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of UseRoflumilast tablets is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.</IndicationAndUsage>
<Description>The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is: The drug substance is a white or practically white crystalline powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Roflumilast tablets is supplied as white to off-white, round shaped, uncoated tablets debossed with “R” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg and 500 mcg of roflumilast. Each tablet of roflumilast tablets for oral administration contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>67877-730-87</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (67877-730-87) / 28 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>67877-0730-87</NDC11Code>
<ProductNDC>67877-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roflumilast</ProprietaryName>
<NonProprietaryName>Roflumilast</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212490</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>ROFLUMILAST</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Roflumilast tablets is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of UseRoflumilast tablets is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.</IndicationAndUsage>
<Description>The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is: The drug substance is a white or practically white crystalline powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Roflumilast tablets is supplied as white to off-white, round shaped, uncoated tablets debossed with “R” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg and 500 mcg of roflumilast. Each tablet of roflumilast tablets for oral administration contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>67877-730-93</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (67877-730-93) / 7 TABLET in 1 BLISTER PACK (67877-730-32) </PackageDescription>
<NDC11Code>67877-0730-93</NDC11Code>
<ProductNDC>67877-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roflumilast</ProprietaryName>
<NonProprietaryName>Roflumilast</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212490</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>ROFLUMILAST</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Roflumilast tablets is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of UseRoflumilast tablets is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.</IndicationAndUsage>
<Description>The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is: The drug substance is a white or practically white crystalline powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Roflumilast tablets is supplied as white to off-white, round shaped, uncoated tablets debossed with “R” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg and 500 mcg of roflumilast. Each tablet of roflumilast tablets for oral administration contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>17224-730-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (17224-730-90) </PackageDescription>
<NDC11Code>17224-0730-90</NDC11Code>
<ProductNDC>17224-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diethylpropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Diethylpropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201212</ApplicationNumber>
<LabelerName>Calvin Scott & Co., Inc.</LabelerName>
<SubstanceName>DIETHYLPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diethylpropion hydrochloride is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of BMI based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds divided by 2.2 = kg; inches x 0.0254 = meters. The usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below. Diethylpropion hydrochloride is indicated for use as monotherapy only.</IndicationAndUsage>
<Description>Diethylpropion hydrochloride is available for oral administration in immediate-release tablets containing 25 mg diethylpropion hydrochloride. The inactive ingredients in each immediate-release tablet are: crospovidone, lactose anhydrous, magnesium stearate, starch pregelatinized and tartaric acid. Diethylpropion hydrochloride is a sympathomimetic agent. The chemical name for diethylpropion hydrochloride is 1-phenyl-2-diethylamino-1-propanone hydrochloride. Its chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>23155-730-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (23155-730-09) </PackageDescription>
<NDC11Code>23155-0730-09</NDC11Code>
<ProductNDC>23155-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nadolol</ProprietaryName>
<NonProprietaryName>Nadolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074229</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NADOLOL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>31722-730-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (31722-730-90) </PackageDescription>
<NDC11Code>31722-0730-90</NDC11Code>
<ProductNDC>31722-730</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>ANDA202910</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>IRBESARTAN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Irbesartan tablet is an angiotensin II receptor blocker (ARB) indicated for: 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) 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 (AT 1subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3 -[p-(o-1 H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4] non-1-en-4-one. Its molecular formula is C 25H 28N 6O, and the structural formula:. Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.53. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in ethanol and methylene chloride and practically insoluble in water. Irbesartan is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of irbesartan USP. Inactive ingredients include: calcium stearate, carboxy methyl cellulose calcium, colloidal silicon dioxide, microcrystalline cellulose and povidone.</Description>
</NDC>
<NDC>
<NDCCode>35356-730-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (35356-730-90)</PackageDescription>
<NDC11Code>35356-0730-90</NDC11Code>
<ProductNDC>35356-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075786</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-730-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42291-730-90)</PackageDescription>
<NDC11Code>42291-0730-90</NDC11Code>
<ProductNDC>42291-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078380</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-08</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43063-730-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-730-90) </PackageDescription>
<NDC11Code>43063-0730-90</NDC11Code>
<ProductNDC>43063-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090682</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients(1.1) : 1 Cold Sores (Herpes Labialis), 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-1-infected patientsReduction of transmission, 3 Herpes Zoster .</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 556 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>55289-730-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-730-90) </PackageDescription>
<NDC11Code>55289-0730-90</NDC11Code>
<ProductNDC>55289-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040218</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55700-730-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (55700-730-90) </PackageDescription>
<NDC11Code>55700-0730-90</NDC11Code>
<ProductNDC>55700-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203769</ApplicationNumber>
<LabelerName>Quality Care Products, 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>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains Hypromellose, polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>61786-730-19</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (61786-730-19) </PackageDescription>
<NDC11Code>61786-0730-19</NDC11Code>
<ProductNDC>61786-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074550</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61919-730-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (61919-730-90) </PackageDescription>
<NDC11Code>61919-0730-90</NDC11Code>
<ProductNDC>61919-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078332</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.2 Left Ventricular Dysfunction Following Myocardial Infarction. Carvedilol Tablet is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies ( 14.2)]. 1.3 Hypertension. Carvedilol Tablet is indicated for the management of essential hypertension [see Clinical Studies ( 14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions ( 7.2)].</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol Tablet is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).</Description>
</NDC>
<NDC>
<NDCCode>64764-730-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (64764-730-90) </PackageDescription>
<NDC11Code>64764-0730-90</NDC11Code>
<ProductNDC>64764-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trintellix</ProprietaryName>
<NonProprietaryName>Vortioxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204447</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>VORTIOXETINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg).</Description>
</NDC>
<NDC>
<NDCCode>65841-730-16</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (65841-730-16) </PackageDescription>
<NDC11Code>65841-0730-16</NDC11Code>
<ProductNDC>65841-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078243</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66267-730-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (66267-730-90) </PackageDescription>
<NDC11Code>66267-0730-90</NDC11Code>
<ProductNDC>66267-730</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senna</ProprietaryName>
<ProprietaryNameSuffix>Standardized Senna Concentrate 8.6 Mg Sennosides Each</ProprietaryNameSuffix>
<NonProprietaryName>Sennosides</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060327</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>SENNOSIDES</SubstanceName>
<StrengthNumber>8.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-730-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68180-730-09) </PackageDescription>
<NDC11Code>68180-0730-09</NDC11Code>
<ProductNDC>68180-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205587</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca's CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca's marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to light yellow amorphous powder that is sparingly soluble in water and methanol, and soluble in N, N-Dimethylformamide. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin calcium tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, hypromellose, iron oxide red (in 10 mg, 20 mg and 40 mg), iron oxide yellow (in 5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>76282-730-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (76282-730-90) </PackageDescription>
<NDC11Code>76282-0730-90</NDC11Code>
<ProductNDC>76282-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076102</ApplicationNumber>
<LabelerName>Exelan Pharmaceuticals, Inc</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol.Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – anhydrous lactose, magnesium stearate. 5 mg, 10 mg, 20 mg and 30 mg tablets – anhydrous lactose, magnesium stearate, iron oxide red. 40 mg tablets – anhydrous lactose, magnesium stearate, iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>67877-064-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-064-90) </PackageDescription>
<NDC11Code>67877-0064-90</NDC11Code>
<ProductNDC>67877-064</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fesoterodine Fumarate</ProprietaryName>
<NonProprietaryName>Fesoterodine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204827</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>FESOTERODINE FUMARATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fesoterodine fumarate extended-release tablets are indicated for the treatment of: 1 Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1).</IndicationAndUsage>
<Description>Fesoterodine fumarate extended-release tablets contains fesoterodine fumarate. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1 phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C30H41NO7 and its molecular weight is 527.66. The structural formula is:. The asterisk (*) indicates the chiral carbon. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each fesoterodine fumarate extended-release tablets contains either 4 mg or 8mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, FD&C Blue #2/Indigo carmine aluminum lake, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67877-068-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-068-90) </PackageDescription>
<NDC11Code>67877-0068-90</NDC11Code>
<ProductNDC>67877-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fesoterodine Fumarate</ProprietaryName>
<NonProprietaryName>Fesoterodine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204827</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>FESOTERODINE FUMARATE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fesoterodine fumarate extended-release tablets are indicated for the treatment of: 1 Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1).</IndicationAndUsage>
<Description>Fesoterodine fumarate extended-release tablets contains fesoterodine fumarate. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1 phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C30H41NO7 and its molecular weight is 527.66. The structural formula is:. The asterisk (*) indicates the chiral carbon. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each fesoterodine fumarate extended-release tablets contains either 4 mg or 8mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, FD&C Blue #2/Indigo carmine aluminum lake, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67877-197-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (67877-197-90) </PackageDescription>
<NDC11Code>67877-0197-90</NDC11Code>
<ProductNDC>67877-197</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078925</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension (1.1): 1 Amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl(±)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>67877-198-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (67877-198-90) </PackageDescription>
<NDC11Code>67877-0198-90</NDC11Code>
<ProductNDC>67877-198</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078925</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension (1.1): 1 Amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl(±)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>67877-199-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (67877-199-90) </PackageDescription>
<NDC11Code>67877-0199-90</NDC11Code>
<ProductNDC>67877-199</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078925</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension (1.1): 1 Amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl(±)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>67877-256-90</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (67877-256-90) / 45 TABLET, CHEWABLE in 1 BOTTLE (67877-256-45) </PackageDescription>
<NDC11Code>67877-0256-90</NDC11Code>
<ProductNDC>67877-256</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lanthanum Carbonate</ProprietaryName>
<NonProprietaryName>Lanthanum Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202329</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>LANTHANUM CARBONATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lanthanum carbonate is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.</IndicationAndUsage>
<Description>Lanthanum carbonate chewable tablet contains lanthanum carbonate with molecular formula La2(CO3)3 xH2O (where x=8 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate octahydrate is insoluble in water and soluble in acids. The molecular weight of lanthanum carbonate octahydrate is 601.95 g/mol. Each white to off-white, round flat with a beveled edge chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: maltitol, crospovidone and sodium stearyl fumarate. The chemical structure of lanthanum carbonate octahydrate is.</Description>
</NDC>
<NDC>
<NDCCode>67877-257-90</NDCCode>
<PackageDescription>6 BOTTLE in 1 CARTON (67877-257-90) / 15 TABLET, CHEWABLE in 1 BOTTLE (67877-257-15) </PackageDescription>
<NDC11Code>67877-0257-90</NDC11Code>
<ProductNDC>67877-257</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lanthanum Carbonate</ProprietaryName>
<NonProprietaryName>Lanthanum Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202329</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>LANTHANUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lanthanum carbonate is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.</IndicationAndUsage>
<Description>Lanthanum carbonate chewable tablet contains lanthanum carbonate with molecular formula La2(CO3)3 xH2O (where x=8 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate octahydrate is insoluble in water and soluble in acids. The molecular weight of lanthanum carbonate octahydrate is 601.95 g/mol. Each white to off-white, round flat with a beveled edge chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: maltitol, crospovidone and sodium stearyl fumarate. The chemical structure of lanthanum carbonate octahydrate is.</Description>
</NDC>
<NDC>
<NDCCode>67877-258-90</NDCCode>
<PackageDescription>9 BOTTLE in 1 CARTON (67877-258-90) / 10 TABLET, CHEWABLE in 1 BOTTLE (67877-258-11) </PackageDescription>
<NDC11Code>67877-0258-90</NDC11Code>
<ProductNDC>67877-258</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lanthanum Carbonate</ProprietaryName>
<NonProprietaryName>Lanthanum Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202329</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>LANTHANUM CARBONATE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lanthanum carbonate is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.</IndicationAndUsage>
<Description>Lanthanum carbonate chewable tablet contains lanthanum carbonate with molecular formula La2(CO3)3 xH2O (where x=8 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate octahydrate is insoluble in water and soluble in acids. The molecular weight of lanthanum carbonate octahydrate is 601.95 g/mol. Each white to off-white, round flat with a beveled edge chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: maltitol, crospovidone and sodium stearyl fumarate. The chemical structure of lanthanum carbonate octahydrate is.</Description>
</NDC>
<NDC>
<NDCCode>67877-263-90</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-263-90) </PackageDescription>
<NDC11Code>67877-0263-90</NDC11Code>
<ProductNDC>67877-263</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203197</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water.Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>67877-264-90</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-90) </PackageDescription>
<NDC11Code>67877-0264-90</NDC11Code>
<ProductNDC>67877-264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203197</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water.Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water.</Description>
</NDC>
</NDCList>