{
"NDC": [
{
"NDCCode": "42806-082-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42806-082-05) ",
"NDC11Code": "42806-0082-05",
"ProductNDC": "42806-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208972",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2019-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190417",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "42806-082-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (42806-082-01) ",
"NDC11Code": "42806-0082-01",
"ProductNDC": "42806-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208972",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2019-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190417",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "13107-082-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (13107-082-05) ",
"NDC11Code": "13107-0082-05",
"ProductNDC": "13107-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204852",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150915",
"SamplePackage": "N",
"IndicationAndUsage": "Trazodone Hydrochloride Tablets are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows. Molecular Formula: C19H22CIN5O HCl. Molecular Weight: 408.33. Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (physically modified corn (maize) starch), sodium lauryl sulfate, and sodium starch glycolate."
},
{
"NDCCode": "13668-082-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (13668-082-05) ",
"NDC11Code": "13668-0082-05",
"ProductNDC": "13668-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090722",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110620",
"SamplePackage": "N"
},
{
"NDCCode": "16714-082-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (16714-082-05)",
"NDC11Code": "16714-0082-05",
"ProductNDC": "16714-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040842",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "HYDROXYZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "31722-082-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (31722-082-05) ",
"NDC11Code": "31722-0082-05",
"ProductNDC": "31722-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lurasidone Hydrochloride",
"NonProprietaryName": "Lurasidone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218174",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LURASIDONE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240821",
"SamplePackage": "N",
"IndicationAndUsage": "Lurasidone hydrochloride tablets are indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1)] . Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)]. Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)].",
"Description": "Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in methanol. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are croscarmellose sodium, hypromellose, magnesium stearate, mannitol, polyethylene glycol, pregelatinized starch (maize), and titanium dioxide."
},
{
"NDCCode": "50242-082-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-082-01) > .05 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0082-01",
"ProductNDC": "50242-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lucentis",
"NonProprietaryName": "Ranibizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20120810",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125156",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "RANIBIZUMAB",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120810",
"SamplePackage": "N"
},
{
"NDCCode": "50242-082-02",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-082-02) > .05 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0082-02",
"ProductNDC": "50242-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lucentis",
"NonProprietaryName": "Ranibizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20120810",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125156",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "RANIBIZUMAB",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20161128",
"SamplePackage": "N"
},
{
"NDCCode": "50242-082-03",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (50242-082-03) / .05 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50242-0082-03",
"ProductNDC": "50242-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lucentis",
"NonProprietaryName": "Ranibizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20120810",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125156",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "RANIBIZUMAB",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180320",
"SamplePackage": "N",
"IndicationAndUsage": "LUCENTIS is indicated for the treatment of patients with.",
"Description": "LUCENTIS® (ranibizumab injection) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product. LUCENTIS is a sterile, colorless to pale yellow solution in a single-dose prefilled syringe. LUCENTIS is supplied as a preservative-free, sterile solution in a single-dose container designed to deliver 0.05 mL of 10 mg/mL LUCENTIS (0.5 mg dose prefilled syringe) or 6 mg/mL LUCENTIS (0.3 mg dose prefilled syringe) aqueous solution with 10 mM histidine HCl, 10% α,α-trehalose dihydrate, 0.01% polysorbate 20, pH 5.5."
},
{
"NDCCode": "50242-082-87",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-082-87) > .05 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0082-87",
"ProductNDC": "50242-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lucentis",
"NonProprietaryName": "Ranibizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20120810",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125156",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "RANIBIZUMAB",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170228",
"SamplePackage": "Y"
},
{
"NDCCode": "50242-082-88",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (50242-082-88) / .05 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50242-0082-88",
"ProductNDC": "50242-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lucentis",
"NonProprietaryName": "Ranibizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20120810",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125156",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "RANIBIZUMAB",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180320",
"SamplePackage": "Y",
"IndicationAndUsage": "LUCENTIS is indicated for the treatment of patients with.",
"Description": "LUCENTIS® (ranibizumab injection) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product. LUCENTIS is a sterile, colorless to pale yellow solution in a single-dose prefilled syringe. LUCENTIS is supplied as a preservative-free, sterile solution in a single-dose container designed to deliver 0.05 mL of 10 mg/mL LUCENTIS (0.5 mg dose prefilled syringe) or 6 mg/mL LUCENTIS (0.3 mg dose prefilled syringe) aqueous solution with 10 mM histidine HCl, 10% α,α-trehalose dihydrate, 0.01% polysorbate 20, pH 5.5."
},
{
"NDCCode": "52959-082-05",
"PackageDescription": "5 CAPSULE in 1 CONTAINER (52959-082-05) ",
"NDC11Code": "52959-0082-05",
"ProductNDC": "52959-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Extended-release",
"NonProprietaryName": "Indomethacin Extended-release",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202706",
"LabelerName": "H. J. Harkins Company inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170221",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin extended-release capsules are indicated for:. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. Moderate to severe ankylosing spondylitis. Moderate to severe osteoarthritis. Acute painful shoulder (bursitis and/or tendinitis).",
"Description": "domethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. Each extended-release capsule, for oral administration contains 75 mg of indomethacin, USP. In addition, each capsule contains the following inactive ingredients: corn starch, ethyl cellulose, ferric oxide black, gelatin, potassium hydroxide, povidone, propylene glycol, shellac, sucrose, and talc. This product meets USP Dissolution Test 2."
},
{
"NDCCode": "58159-082-05",
"PackageDescription": "5 kg in 1 DRUM (58159-082-05) ",
"NDC11Code": "58159-0082-05",
"ProductNDC": "58159-082",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tranylcypromine Sulfate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250102",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
"SubstanceName": "TRANYLCYPROMINE SULFATE",
"StrengthNumber": "35",
"StrengthUnit": "kg/35kg",
"Status": "Unfinished",
"LastUpdate": "2025-01-14",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "02-JAN-25"
},
{
"NDCCode": "65862-082-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65862-082-05) ",
"NDC11Code": "65862-0082-05",
"ProductNDC": "65862-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide And Metformin Hydrochloride",
"NonProprietaryName": "Glyburide And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077870",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071114",
"SamplePackage": "N",
"IndicationAndUsage": "Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide USP and metformin hydrochloride USP. Glyburide USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide USP is a white to off-white crystalline compound with molecular formula of C23H28ClN3O5S and a molecular weight of 494.01. The structural formula is represented below. Metformin hydrochloride USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white to off-white crystalline compound with molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.63. Metformin is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin is 6.68. The structural formula is as shown:. Glyburide and metformin hydrochloride tablets, USP are available in film-coated containing 1.25 mg glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg glyburide USP with 500 mg metformin hydrochloride USP, and 5 mg glyburide USP with 500 mg metformin hydrochloride USP. In addition, each film-coated tablet contains the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, hypromellose, propylene glycol, polysorbate 80, talc, titanium dioxide and FD&C Yellow#6 aluminum lake. The 1.25 mg/250 mg and 5 mg/500 mg strengths also contain D&C Yellow#10 aluminum lake; The 2.5 mg/500 mg strength also contains FD&C Red#40 aluminum lake. Meets USP Dissolution Test 2."
},
{
"NDCCode": "69804-082-05",
"PackageDescription": "28500 mg in 1 JAR (69804-082-05) ",
"NDC11Code": "69804-0082-05",
"ProductNDC": "69804-082",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Numbify Smooth",
"NonProprietaryName": "Lidocaine Hcl",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200619",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Ridge properties",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1000mg",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200619",
"SamplePackage": "N"
},
{
"NDCCode": "71209-082-05",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (71209-082-05) ",
"NDC11Code": "71209-0082-05",
"ProductNDC": "71209-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Raloxifene Hydrochloride",
"NonProprietaryName": "Raloxifene Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211324",
"LabelerName": "Cadila Pharmaceuticals Limited",
"SubstanceName": "RALOXIFENE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2022-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171230",
"SamplePackage": "N",
"IndicationAndUsage": "Raloxifene hydrochloride is an estrogen agonist/antagonist indicated for. Important Limitations: Raloxifene hydrochloride is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer. (1.3).",
"Description": "Raloxifene hydrochloride, USP is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:. The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl) benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl), USP has the empirical formula C28H27NO4SHCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl, USP is an off-white to pale-yellow solid that is very slightly soluble in water. Raloxifene hydrochloride, USP is supplied in a tablet dosage form for oral administration. Each raloxifene hydrochloride tablet, USP contains 60 mg of raloxifene HCl, which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include crospovidone, hypromellose, lactose monohydrate, lactose anhydrous, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone and titanium dioxide."
},
{
"NDCCode": "73212-082-05",
"PackageDescription": "5 g in 1 BOTTLE (73212-082-05) ",
"NDC11Code": "73212-0082-05",
"ProductNDC": "73212-082",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mk-2866",
"DosageFormName": "POWDER",
"StartMarketingDate": "20231101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Qingdao Biopeptek Co., Ltd.",
"SubstanceName": "ENOBOSARM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-01-12",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "01-NOV-23"
},
{
"NDCCode": "73731-082-05",
"PackageDescription": "150 mL in 1 TUBE (73731-082-05) ",
"NDC11Code": "73731-0082-05",
"ProductNDC": "73731-082",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Malie Organics Reef Safe Sunscreen Spf-30",
"NonProprietaryName": "Homosalate, Octisalate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200320",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Malie, Inc.",
"SubstanceName": "HOMOSALATE; OCTISALATE; ZINC OXIDE",
"StrengthNumber": "100; 50; 50",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200320",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF for 80 minutes of swimming or sweating . If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions."
},
{
"NDCCode": "42806-011-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42806-011-05) ",
"NDC11Code": "42806-0011-05",
"ProductNDC": "42806-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulindac",
"NonProprietaryName": "Sulindac",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072711",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "SULINDAC",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100125",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following. 1. Osteoarthritis. 2. Rheumatoid arthritis**. 3. Ankylosing spondylitis. 4. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis). 5. Acute gouty arthritis. **The safety and effectiveness of sulindac tablets USP have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (incapacitated, largely or wholly bedridden, or confined to wheelchair, little or no self-care).",
"Description": "Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1- [[p-(methylsulfinyl) phenyl]methylene] -1 H-indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C 20H 17FO 3S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher. Sulindac is available in 150 and 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, plasdone and sodium starch glycolate. Following absorption, sulindac undergoes two major biotransformations - reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite. The structural formulas of sulindac and its metabolites are."
},
{
"NDCCode": "42806-018-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42806-018-05) ",
"NDC11Code": "42806-0018-05",
"ProductNDC": "42806-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulindac",
"NonProprietaryName": "Sulindac",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072710",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "SULINDAC",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100125",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following. 1. Osteoarthritis. 2. Rheumatoid arthritis**. 3. Ankylosing spondylitis. 4. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis). 5. Acute gouty arthritis. **The safety and effectiveness of sulindac tablets USP have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (incapacitated, largely or wholly bedridden, or confined to wheelchair, little or no self-care).",
"Description": "Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1- [[p-(methylsulfinyl) phenyl]methylene] -1 H-indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C 20H 17FO 3S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher. Sulindac is available in 150 and 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, plasdone and sodium starch glycolate. Following absorption, sulindac undergoes two major biotransformations - reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite. The structural formulas of sulindac and its metabolites are."
},
{
"NDCCode": "42806-019-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (42806-019-05)",
"NDC11Code": "42806-0019-05",
"ProductNDC": "42806-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077045",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "42806-020-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (42806-020-05)",
"NDC11Code": "42806-0020-05",
"ProductNDC": "42806-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077045",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "42806-021-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (42806-021-05)",
"NDC11Code": "42806-0021-05",
"ProductNDC": "42806-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077045",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "42806-048-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42806-048-05) ",
"NDC11Code": "42806-0048-05",
"ProductNDC": "42806-048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Guanfacine",
"NonProprietaryName": "Guanfacine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131202",
"EndMarketingDate": "20180930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074673",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "GUANFACINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131202",
"EndMarketingDatePackage": "20180930",
"SamplePackage": "N"
},
{
"NDCCode": "42806-049-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42806-049-05) ",
"NDC11Code": "42806-0049-05",
"ProductNDC": "42806-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Guanfacine",
"NonProprietaryName": "Guanfacine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131202",
"EndMarketingDate": "20180731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074673",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "GUANFACINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131202",
"EndMarketingDatePackage": "20180731",
"SamplePackage": "N"
},
{
"NDCCode": "42806-055-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42806-055-05) ",
"NDC11Code": "42806-0055-05",
"ProductNDC": "42806-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078552",
"LabelerName": "Epic Pharma, 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": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110425",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)oAmlodipine besylate tablets are 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., 2 Coronary Artery Disease (1.2)oChronic Stable AnginaoVasospastic Angina (Prinzmetal’s or Variant Angina)oAngiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"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 empirical formula is C20H25CIN2O5 C6H6O3S, 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, corn starch, sodium starch glycolate and magnesium stearate. Meet USP Dissolution Test 1."
},
{
"NDCCode": "42806-056-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42806-056-05) ",
"NDC11Code": "42806-0056-05",
"ProductNDC": "42806-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078552",
"LabelerName": "Epic Pharma, 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": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110425",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)oAmlodipine besylate tablets are 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., 2 Coronary Artery Disease (1.2)oChronic Stable AnginaoVasospastic Angina (Prinzmetal’s or Variant Angina)oAngiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"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 empirical formula is C20H25CIN2O5 C6H6O3S, 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, corn starch, sodium starch glycolate and magnesium stearate. Meet USP Dissolution Test 1."
},
{
"NDCCode": "42806-057-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42806-057-05) ",
"NDC11Code": "42806-0057-05",
"ProductNDC": "42806-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078552",
"LabelerName": "Epic Pharma, 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": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110425",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)oAmlodipine besylate tablets are 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., 2 Coronary Artery Disease (1.2)oChronic Stable AnginaoVasospastic Angina (Prinzmetal’s or Variant Angina)oAngiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"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 empirical formula is C20H25CIN2O5 C6H6O3S, 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, corn starch, sodium starch glycolate and magnesium stearate. Meet USP Dissolution Test 1."
},
{
"NDCCode": "42806-081-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (42806-081-05) ",
"NDC11Code": "42806-0081-05",
"ProductNDC": "42806-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzphetamine Hydrochloride",
"NonProprietaryName": "Benzphetamine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090346",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "BENZPHETAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
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"IndicationAndUsage": "Benzphetamine Hydrochloride Tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (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 ÷2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below. Benzphetamine Hydrochloride Tablets are indicated for use as monotherapy only.",
"Description": "Benzphetamine Hydrochloride Tablets contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N, α-Dimethyl-N-(phenylmethyl)-benzeneethanamine hydrochloride and its molecular weight is 275.82. The structural formula (dextro form) is represented below:. Each film-coated tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride. In addition, each film-coated tablet contains the following inactive ingredients: crospovidone, carnauba wax, FD&C Red #40, FD&C Yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol, silicon dioxide, and titanium dioxide."
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"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
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<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
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<PackageDescription>500 TABLET in 1 BOTTLE (13107-082-05) </PackageDescription>
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<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
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<IndicationAndUsage>Trazodone Hydrochloride Tablets are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows. Molecular Formula: C19H22CIN5O HCl. Molecular Weight: 408.33. Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (physically modified corn (maize) starch), sodium lauryl sulfate, and sodium starch glycolate.</Description>
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<ProprietaryName>Levofloxacin</ProprietaryName>
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<SubstanceName>LEVOFLOXACIN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<SamplePackage>N</SamplePackage>
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<ProductNDC>16714-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040842</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>HYDROXYZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>31722-082-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (31722-082-05) </PackageDescription>
<NDC11Code>31722-0082-05</NDC11Code>
<ProductNDC>31722-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240821</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218174</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
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<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1)] . Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)]. Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)].</IndicationAndUsage>
<Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in methanol. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are croscarmellose sodium, hypromellose, magnesium stearate, mannitol, polyethylene glycol, pregelatinized starch (maize), and titanium dioxide.</Description>
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<ProductNDC>50242-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lucentis</ProprietaryName>
<NonProprietaryName>Ranibizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<LastUpdate>2023-08-19</LastUpdate>
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<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<ProprietaryName>Lucentis</ProprietaryName>
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<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<LabelerName>Genentech, Inc.</LabelerName>
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<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180320</StartMarketingDatePackage>
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<IndicationAndUsage>LUCENTIS is indicated for the treatment of patients with.</IndicationAndUsage>
<Description>LUCENTIS® (ranibizumab injection) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product. LUCENTIS is a sterile, colorless to pale yellow solution in a single-dose prefilled syringe. LUCENTIS is supplied as a preservative-free, sterile solution in a single-dose container designed to deliver 0.05 mL of 10 mg/mL LUCENTIS (0.5 mg dose prefilled syringe) or 6 mg/mL LUCENTIS (0.3 mg dose prefilled syringe) aqueous solution with 10 mM histidine HCl, 10% α,α-trehalose dihydrate, 0.01% polysorbate 20, pH 5.5.</Description>
</NDC>
<NDC>
<NDCCode>50242-082-87</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-082-87) > .05 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0082-87</NDC11Code>
<ProductNDC>50242-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lucentis</ProprietaryName>
<NonProprietaryName>Ranibizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20120810</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125156</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>RANIBIZUMAB</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170228</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>50242-082-88</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (50242-082-88) / .05 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50242-0082-88</NDC11Code>
<ProductNDC>50242-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lucentis</ProprietaryName>
<NonProprietaryName>Ranibizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20120810</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125156</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>RANIBIZUMAB</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180320</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LUCENTIS is indicated for the treatment of patients with.</IndicationAndUsage>
<Description>LUCENTIS® (ranibizumab injection) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product. LUCENTIS is a sterile, colorless to pale yellow solution in a single-dose prefilled syringe. LUCENTIS is supplied as a preservative-free, sterile solution in a single-dose container designed to deliver 0.05 mL of 10 mg/mL LUCENTIS (0.5 mg dose prefilled syringe) or 6 mg/mL LUCENTIS (0.3 mg dose prefilled syringe) aqueous solution with 10 mM histidine HCl, 10% α,α-trehalose dihydrate, 0.01% polysorbate 20, pH 5.5.</Description>
</NDC>
<NDC>
<NDCCode>52959-082-05</NDCCode>
<PackageDescription>5 CAPSULE in 1 CONTAINER (52959-082-05) </PackageDescription>
<NDC11Code>52959-0082-05</NDC11Code>
<ProductNDC>52959-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Extended-release</ProprietaryName>
<NonProprietaryName>Indomethacin Extended-release</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202706</ApplicationNumber>
<LabelerName>H. J. Harkins Company inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin extended-release capsules are indicated for:. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. Moderate to severe ankylosing spondylitis. Moderate to severe osteoarthritis. Acute painful shoulder (bursitis and/or tendinitis).</IndicationAndUsage>
<Description>domethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. Each extended-release capsule, for oral administration contains 75 mg of indomethacin, USP. In addition, each capsule contains the following inactive ingredients: corn starch, ethyl cellulose, ferric oxide black, gelatin, potassium hydroxide, povidone, propylene glycol, shellac, sucrose, and talc. This product meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>58159-082-05</NDCCode>
<PackageDescription>5 kg in 1 DRUM (58159-082-05) </PackageDescription>
<NDC11Code>58159-0082-05</NDC11Code>
<ProductNDC>58159-082</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tranylcypromine Sulfate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250102</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
<SubstanceName>TRANYLCYPROMINE SULFATE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>kg/35kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-14</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JAN-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65862-082-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65862-082-05) </PackageDescription>
<NDC11Code>65862-0082-05</NDC11Code>
<ProductNDC>65862-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077870</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide USP and metformin hydrochloride USP. Glyburide USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide USP is a white to off-white crystalline compound with molecular formula of C23H28ClN3O5S and a molecular weight of 494.01. The structural formula is represented below. Metformin hydrochloride USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white to off-white crystalline compound with molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.63. Metformin is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin is 6.68. The structural formula is as shown:. Glyburide and metformin hydrochloride tablets, USP are available in film-coated containing 1.25 mg glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg glyburide USP with 500 mg metformin hydrochloride USP, and 5 mg glyburide USP with 500 mg metformin hydrochloride USP. In addition, each film-coated tablet contains the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, hypromellose, propylene glycol, polysorbate 80, talc, titanium dioxide and FD&C Yellow#6 aluminum lake. The 1.25 mg/250 mg and 5 mg/500 mg strengths also contain D&C Yellow#10 aluminum lake; The 2.5 mg/500 mg strength also contains FD&C Red#40 aluminum lake. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69804-082-05</NDCCode>
<PackageDescription>28500 mg in 1 JAR (69804-082-05) </PackageDescription>
<NDC11Code>69804-0082-05</NDC11Code>
<ProductNDC>69804-082</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Numbify Smooth</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200619</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Ridge properties</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1000mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71209-082-05</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (71209-082-05) </PackageDescription>
<NDC11Code>71209-0082-05</NDC11Code>
<ProductNDC>71209-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Raloxifene Hydrochloride</ProprietaryName>
<NonProprietaryName>Raloxifene Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211324</ApplicationNumber>
<LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
<SubstanceName>RALOXIFENE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Raloxifene hydrochloride is an estrogen agonist/antagonist indicated for. Important Limitations: Raloxifene hydrochloride is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer. (1.3).</IndicationAndUsage>
<Description>Raloxifene hydrochloride, USP is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:. The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl) benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl), USP has the empirical formula C28H27NO4SHCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl, USP is an off-white to pale-yellow solid that is very slightly soluble in water. Raloxifene hydrochloride, USP is supplied in a tablet dosage form for oral administration. Each raloxifene hydrochloride tablet, USP contains 60 mg of raloxifene HCl, which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include crospovidone, hypromellose, lactose monohydrate, lactose anhydrous, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>73212-082-05</NDCCode>
<PackageDescription>5 g in 1 BOTTLE (73212-082-05) </PackageDescription>
<NDC11Code>73212-0082-05</NDC11Code>
<ProductNDC>73212-082</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mk-2866</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20231101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Qingdao Biopeptek Co., Ltd.</LabelerName>
<SubstanceName>ENOBOSARM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-01-12</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-NOV-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>73731-082-05</NDCCode>
<PackageDescription>150 mL in 1 TUBE (73731-082-05) </PackageDescription>
<NDC11Code>73731-0082-05</NDC11Code>
<ProductNDC>73731-082</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Malie Organics Reef Safe Sunscreen Spf-30</ProprietaryName>
<NonProprietaryName>Homosalate, Octisalate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200320</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Malie, Inc.</LabelerName>
<SubstanceName>HOMOSALATE; OCTISALATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>100; 50; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF for 80 minutes of swimming or sweating . If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42806-011-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42806-011-05) </PackageDescription>
<NDC11Code>42806-0011-05</NDC11Code>
<ProductNDC>42806-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulindac</ProprietaryName>
<NonProprietaryName>Sulindac</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072711</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>SULINDAC</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following. 1. Osteoarthritis. 2. Rheumatoid arthritis**. 3. Ankylosing spondylitis. 4. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis). 5. Acute gouty arthritis. **The safety and effectiveness of sulindac tablets USP have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (incapacitated, largely or wholly bedridden, or confined to wheelchair, little or no self-care).</IndicationAndUsage>
<Description>Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1- [[p-(methylsulfinyl) phenyl]methylene] -1 H-indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C 20H 17FO 3S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher. Sulindac is available in 150 and 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, plasdone and sodium starch glycolate. Following absorption, sulindac undergoes two major biotransformations - reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite. The structural formulas of sulindac and its metabolites are.</Description>
</NDC>
<NDC>
<NDCCode>42806-018-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42806-018-05) </PackageDescription>
<NDC11Code>42806-0018-05</NDC11Code>
<ProductNDC>42806-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulindac</ProprietaryName>
<NonProprietaryName>Sulindac</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072710</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>SULINDAC</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following. 1. Osteoarthritis. 2. Rheumatoid arthritis**. 3. Ankylosing spondylitis. 4. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis). 5. Acute gouty arthritis. **The safety and effectiveness of sulindac tablets USP have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (incapacitated, largely or wholly bedridden, or confined to wheelchair, little or no self-care).</IndicationAndUsage>
<Description>Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1- [[p-(methylsulfinyl) phenyl]methylene] -1 H-indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C 20H 17FO 3S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher. Sulindac is available in 150 and 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, plasdone and sodium starch glycolate. Following absorption, sulindac undergoes two major biotransformations - reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite. The structural formulas of sulindac and its metabolites are.</Description>
</NDC>
<NDC>
<NDCCode>42806-019-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42806-019-05)</PackageDescription>
<NDC11Code>42806-0019-05</NDC11Code>
<ProductNDC>42806-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077045</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>42806-020-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42806-020-05)</PackageDescription>
<NDC11Code>42806-0020-05</NDC11Code>
<ProductNDC>42806-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077045</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>42806-021-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42806-021-05)</PackageDescription>
<NDC11Code>42806-0021-05</NDC11Code>
<ProductNDC>42806-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077045</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>42806-048-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42806-048-05) </PackageDescription>
<NDC11Code>42806-0048-05</NDC11Code>
<ProductNDC>42806-048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Guanfacine</ProprietaryName>
<NonProprietaryName>Guanfacine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131202</StartMarketingDate>
<EndMarketingDate>20180930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074673</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>GUANFACINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131202</StartMarketingDatePackage>
<EndMarketingDatePackage>20180930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42806-049-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42806-049-05) </PackageDescription>
<NDC11Code>42806-0049-05</NDC11Code>
<ProductNDC>42806-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Guanfacine</ProprietaryName>
<NonProprietaryName>Guanfacine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131202</StartMarketingDate>
<EndMarketingDate>20180731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074673</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>GUANFACINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131202</StartMarketingDatePackage>
<EndMarketingDatePackage>20180731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42806-055-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42806-055-05) </PackageDescription>
<NDC11Code>42806-0055-05</NDC11Code>
<ProductNDC>42806-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110425</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078552</ApplicationNumber>
<LabelerName>Epic Pharma, 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>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)oAmlodipine besylate tablets are 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., 2 Coronary Artery Disease (1.2)oChronic Stable AnginaoVasospastic Angina (Prinzmetal’s or Variant Angina)oAngiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</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 empirical formula is C20H25CIN2O5 C6H6O3S, 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, corn starch, sodium starch glycolate and magnesium stearate. Meet USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42806-056-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42806-056-05) </PackageDescription>
<NDC11Code>42806-0056-05</NDC11Code>
<ProductNDC>42806-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110425</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078552</ApplicationNumber>
<LabelerName>Epic Pharma, 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>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)oAmlodipine besylate tablets are 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., 2 Coronary Artery Disease (1.2)oChronic Stable AnginaoVasospastic Angina (Prinzmetal’s or Variant Angina)oAngiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</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 empirical formula is C20H25CIN2O5 C6H6O3S, 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, corn starch, sodium starch glycolate and magnesium stearate. Meet USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42806-057-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42806-057-05) </PackageDescription>
<NDC11Code>42806-0057-05</NDC11Code>
<ProductNDC>42806-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110425</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078552</ApplicationNumber>
<LabelerName>Epic Pharma, 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>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)oAmlodipine besylate tablets are 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., 2 Coronary Artery Disease (1.2)oChronic Stable AnginaoVasospastic Angina (Prinzmetal’s or Variant Angina)oAngiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</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 empirical formula is C20H25CIN2O5 C6H6O3S, 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, corn starch, sodium starch glycolate and magnesium stearate. Meet USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42806-081-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42806-081-05) </PackageDescription>
<NDC11Code>42806-0081-05</NDC11Code>
<ProductNDC>42806-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzphetamine Hydrochloride</ProprietaryName>
<NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090346</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>BENZPHETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzphetamine Hydrochloride Tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (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 ÷2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below. Benzphetamine Hydrochloride Tablets are indicated for use as monotherapy only.</IndicationAndUsage>
<Description>Benzphetamine Hydrochloride Tablets contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N, α-Dimethyl-N-(phenylmethyl)-benzeneethanamine hydrochloride and its molecular weight is 275.82. The structural formula (dextro form) is represented below:. Each film-coated tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride. In addition, each film-coated tablet contains the following inactive ingredients: crospovidone, carnauba wax, FD&C Red #40, FD&C Yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol, silicon dioxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42806-083-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42806-083-05) </PackageDescription>
<NDC11Code>42806-0083-05</NDC11Code>
<ProductNDC>42806-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208972</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2019-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
</NDCList>