{
"NDC": [
{
"NDCCode": "81279-126-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (81279-126-60) ",
"NDC11Code": "81279-0126-60",
"ProductNDC": "81279-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219319",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260522",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules USP is gabapentin USP, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pKa 1of 3.7 and a pKa 2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin capsule contains 200 mg of gabapentin and the following inactive ingredients. Pregelatinized maize starch, talc, magnesium stearate, gelatin, titanium dioxide, red iron oxide. Ingredient of imprinting ink (TekPrint TMSB-6018 Blue Ink) are Shellac NF, Dehydrated Alcohol USP, Isopropyl Alcohol USP, Butyl Alcohol NF, Propylene Glycol USP, Strong Ammonia Solution NF, FD & C Blue # 2 Aluminum Lake. FDA approved dissolution test specifications differ from the USP."
},
{
"NDCCode": "81279-117-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (81279-117-60) ",
"NDC11Code": "81279-0117-60",
"ProductNDC": "81279-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088149",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "Allergic states:Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.",
"Description": "Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α,-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. C 22H 29FO 5 MW 392.47. DEXLYT TM, for oral administration, contains 0.25 mgof dexamethasone. Each tablet contains the following inactive ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, stearic acid and FD&C Yellow #6."
},
{
"NDCCode": "81279-117-88",
"PackageDescription": "60 TABLET in 1 BOTTLE (81279-117-88) ",
"NDC11Code": "81279-0117-88",
"ProductNDC": "81279-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088149",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.",
"Description": "Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α,-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. C 22H 29FO 5 MW 392.47. Each tablet, for oral administration, contains 0.25 mgof dexamethasone. Each tablet contains the following inactive ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, stearic acid and FD&C Yellow #6."
},
{
"NDCCode": "81279-121-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (81279-121-60) ",
"NDC11Code": "81279-0121-60",
"ProductNDC": "81279-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bucapsol",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218628",
"LabelerName": "PANGEA PHARMACEUTICALS, LLC",
"SubstanceName": "BUSPIRONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260709",
"SamplePackage": "N",
"IndicationAndUsage": "Bucapsol TMcapsules 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 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 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, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 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. 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. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge\", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Bucapsol TMcapsules are antianxiety agents that are 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 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2∙HCl is represented by the following structural formula:. Bucapsol TMcapsules are supplied as capsules for oral administration. Bucapsol TMcapsules contains 5 mg, 7.5 mg, 10 mg, or 15 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.8 mg, 9.1 mg, and 13.7 mg of buspirone free base, respectively) in a hard gelatin shell. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The shell consists of black ink, gelatin, titanium dioxide, fd&c blue no. 1 (7.5 mg, 10 mg, and 15 mg), and black iron oxide (10 mg) and is imprinted with edible ink."
},
{
"NDCCode": "81279-122-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (81279-122-60) ",
"NDC11Code": "81279-0122-60",
"ProductNDC": "81279-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bucapsol",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218628",
"LabelerName": "PANGEA PHARMACEUTICALS, LLC",
"SubstanceName": "BUSPIRONE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260410",
"SamplePackage": "N",
"IndicationAndUsage": "Bucapsol TMcapsules 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 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 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, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 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. 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. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge\", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Bucapsol TMcapsules are antianxiety agents that are 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 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2∙HCl is represented by the following structural formula:. Bucapsol TMcapsules are supplied as capsules for oral administration. Bucapsol TMcapsules contains 5 mg, 7.5 mg, 10 mg, or 15 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.8 mg, 9.1 mg, and 13.7 mg of buspirone free base, respectively) in a hard gelatin shell. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The shell consists of black ink, gelatin, titanium dioxide, fd&c blue no. 1 (7.5 mg, 10 mg, and 15 mg), and black iron oxide (10 mg) and is imprinted with edible ink."
},
{
"NDCCode": "81279-123-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (81279-123-60) ",
"NDC11Code": "81279-0123-60",
"ProductNDC": "81279-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bucapsol",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218628",
"LabelerName": "PANGEA PHARMACEUTICALS, LLC",
"SubstanceName": "BUSPIRONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251229",
"SamplePackage": "N",
"IndicationAndUsage": "Bucapsol TMcapsules 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 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 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, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 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. 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. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge\", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Bucapsol TMcapsules are antianxiety agents that are 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 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2∙HCl is represented by the following structural formula:. Bucapsol TMcapsules are supplied as capsules for oral administration. Bucapsol TMcapsules contains 5 mg, 7.5 mg, 10 mg, or 15 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.8 mg, 9.1 mg, and 13.7 mg of buspirone free base, respectively) in a hard gelatin shell. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The shell consists of black ink, gelatin, titanium dioxide, fd&c blue no. 1 (7.5 mg, 10 mg, and 15 mg), and black iron oxide (10 mg) and is imprinted with edible ink."
},
{
"NDCCode": "81279-124-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (81279-124-60) ",
"NDC11Code": "81279-0124-60",
"ProductNDC": "81279-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bucapsol",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218628",
"LabelerName": "PANGEA PHARMACEUTICALS, LLC",
"SubstanceName": "BUSPIRONE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250714",
"SamplePackage": "N",
"IndicationAndUsage": "Bucapsol TMcapsules 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 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 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, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 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. 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. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge\", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Bucapsol TMcapsules are antianxiety agents that are 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 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2∙HCl is represented by the following structural formula:. Bucapsol TMcapsules are supplied as capsules for oral administration. Bucapsol TMcapsules contains 5 mg, 7.5 mg, 10 mg, or 15 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.8 mg, 9.1 mg, and 13.7 mg of buspirone free base, respectively) in a hard gelatin shell. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The shell consists of black ink, gelatin, titanium dioxide, fd&c blue no. 1 (7.5 mg, 10 mg, and 15 mg), and black iron oxide (10 mg) and is imprinted with edible ink."
},
{
"NDCCode": "81279-129-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (81279-129-60) ",
"NDC11Code": "81279-0129-60",
"ProductNDC": "81279-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyproheptadine Hydrochloride",
"NonProprietaryName": "Cyproheptadine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20261012",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212491",
"LabelerName": "PANGEA PHARMACEUTICALS, LLC",
"SubstanceName": "CYPROHEPTADINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261012",
"SamplePackage": "N"
},
{
"NDCCode": "81279-130-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (81279-130-60) ",
"NDC11Code": "81279-0130-60",
"ProductNDC": "81279-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ursolign",
"NonProprietaryName": "Ursodiol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210344",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": "URSODIOL",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bile Acid [EPC], Bile Acids and Salts [CS]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260615",
"SamplePackage": "N",
"IndicationAndUsage": "URSOLIGNTM is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of URSOLIGNTM beyond 24 months is not established. URSOLIGNTM is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.",
"Description": "URSOLIGNTM is a bile acid available as 150 mg capsules suitable for oral administration. URSOLIGNTM is ursodiol, USP (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white or almost white crystalline powder freely soluble in alcohol; slightly soluble in acetone and in methylene chloride; very slightly soluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below. Ursodiol Capsules 150 mg contains following inactive ingredients: Corn starch, colloidal silicon dioxide, magnesium stearate, talc, citric acid, titanium dioxide, gelatin and glycine. The imprinting ink contains shellac, black iron oxide and traces of potassium hydroxide."
},
{
"NDCCode": "16571-126-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (16571-126-06) ",
"NDC11Code": "16571-0126-06",
"ProductNDC": "16571-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204721",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200124",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.",
"Description": "Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7 , and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, opadry white 03A18585 [hypromellose, purified stearic acid, titanium dioxide, microcrystalline cellulose]."
},
{
"NDCCode": "16590-126-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (16590-126-60)",
"NDC11Code": "16590-0126-60",
"ProductNDC": "16590-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075682",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.",
"Description": "IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water(less than 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide."
},
{
"NDCCode": "21130-126-72",
"PackageDescription": "60 TABLET, CHEWABLE in 1 BOTTLE (21130-126-72) ",
"NDC11Code": "21130-0126-72",
"ProductNDC": "21130-126",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Antacid",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20171102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Safeway",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171102",
"SamplePackage": "N"
},
{
"NDCCode": "24979-126-18",
"PackageDescription": "60 VIAL, SINGLE-USE in 1 CARTON (24979-126-18) / .4 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "24979-0126-18",
"ProductNDC": "24979-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclosporine",
"NonProprietaryName": "Cyclosporine",
"DosageFormName": "EMULSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209064",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "CYCLOSPORINE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260327",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclosporine ophthalmic emulsion 0.05% is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.",
"Description": "Cyclosporine ophthalmic emulsion 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure. Structural Formula. Formula: C62H111N11O12 Mol. Wt.: 1202.6. Cyclosporine is a fine white powder. Cyclosporine ophthalmic emulsion 0.05% appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5-8.0. Each mL of cyclosporine ophthalmic emulsion 0.05% contains: Active: cyclosporine 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer copolymer type A; purified water; and sodium hydroxide to adjust pH."
},
{
"NDCCode": "27241-126-02",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-126-02) ",
"NDC11Code": "27241-0126-02",
"ProductNDC": "27241-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210054",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190823",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine extended-release tablets are available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an molecular formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white powder. Ranolazine is soluble in methanol; sparingly soluble in acetonitrile; slightly soluble in isopropyl alcohol and very slightly soluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: Hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer (sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose, polyethylene glycol and sodium hydroxide. The color coating contains titanium dioxide, polyvinyl alcohol, talc, hypromellose, polyethylene glycol, Iron Oxide Yellow, and Iron Oxide Red."
},
{
"NDCCode": "35356-126-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-126-60)",
"NDC11Code": "35356-0126-60",
"ProductNDC": "35356-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Theophylline",
"NonProprietaryName": "Theophylline",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089808",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "THEOPHYLLINE ANHYDROUS",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-02-17"
},
{
"NDCCode": "43063-126-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-126-60) ",
"NDC11Code": "43063-0126-60",
"ProductNDC": "43063-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078332",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "3.125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131030",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: : 1 mild to severe chronic heart failure ( 1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2."
},
{
"NDCCode": "43744-126-60",
"PackageDescription": "750 g in 1 DRUM (43744-126-60)",
"NDC11Code": "43744-0126-60",
"ProductNDC": "43744-126",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Carbimazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110707",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "CARBIMAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "52959-126-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (52959-126-60)",
"NDC11Code": "52959-0126-60",
"ProductNDC": "52959-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040256",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis, 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis, 4 Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis, 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis, 7 Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus, 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
"Description": "PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg."
},
{
"NDCCode": "53045-126-60",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (53045-126-60) ",
"NDC11Code": "53045-0126-60",
"ProductNDC": "53045-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iolite-s",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "SPRAY",
"RouteName": "DENTAL",
"StartMarketingDate": "20210104",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Dharma Research, Inc.",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": "12",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210104",
"SamplePackage": "N"
},
{
"NDCCode": "59115-126-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (59115-126-60)",
"NDC11Code": "59115-0126-60",
"ProductNDC": "59115-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091185",
"LabelerName": "Hikma Pharmaceutical",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-08-02"
},
{
"NDCCode": "61919-126-72",
"PackageDescription": "120 BOTTLE in 1 BOTTLE (61919-126-72) > 90 BOTTLE in 1 BOTTLE (61919-126-90) > 60 BOTTLE in 1 BOTTLE (61919-126-60) > 30 TABLET, FILM COATED in 1 BOTTLE (61919-126-30)",
"NDC11Code": "61919-0126-72",
"ProductNDC": "61919-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "Direct Rx",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
},
{
"NDCCode": "64950-126-06",
"PackageDescription": "1 TUBE in 1 CARTON (64950-126-06) / 60 g in 1 TUBE",
"NDC11Code": "64950-0126-06",
"ProductNDC": "64950-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Halog",
"NonProprietaryName": "Halcinonide Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260113",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017556",
"LabelerName": "Genus Lifesciences Inc.",
"SubstanceName": "HALCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260113",
"SamplePackage": "N",
"IndicationAndUsage": "HALOG (Halcinonide Cream, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. Halcinonide, USP is designated chemically as 21-Chloro-9-fluoro-11β, 16α, 17-trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. Graphic formula. Each gram of 0.1% HALOG (Halcinonide Cream, USP) contains 1 mg halcinonide, USP in a specially formulated cream base consisting of cetyl alcohol, dimethicone 350, glyceryl monostearate, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and titanium dioxide."
},
{
"NDCCode": "66267-126-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (66267-126-60) ",
"NDC11Code": "66267-0126-60",
"ProductNDC": "66267-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoprofen",
"NonProprietaryName": "Ketoprofen",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19930101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073517",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "KETOPROFEN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20161010",
"SamplePackage": "N"
},
{
"NDCCode": "69452-126-19",
"PackageDescription": "90 PACKET in 1 CARTON (69452-126-19) / 1 POWDER, FOR SUSPENSION in 1 PACKET (69452-126-60) ",
"NDC11Code": "69452-0126-19",
"ProductNDC": "69452-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sevelamer Carbonate",
"NonProprietaryName": "Sevelamer Carbonate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209374",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "SEVELAMER CARBONATE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Sevelamer carbonate for oral suspension is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.",
"Description": "The active ingredient in sevelamer carbonate for oral suspension is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate-binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine- co-N,N’-diallyl-1,3diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water and other solvents. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Carbonate. a, b = number of primary amine groups a + b = 9. c = number of cross-linking groups c = 1. m = large number to indicate extended polymer network. Each packet of sevelamer carbonate powder contains 0.8 g or 2.4 g of sevelamer carbonate on an anhydrous basis. The inactive ingredients are lemon flavor, propylene glycol alginate, silicon dioxide, sodium chloride, and sucralose."
},
{
"NDCCode": "70010-126-06",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-126-06) ",
"NDC11Code": "70010-0126-06",
"ProductNDC": "70010-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218385",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250331",
"SamplePackage": "N"
},
{
"NDCCode": "70658-126-31",
"PackageDescription": "60 mL in 1 BOTTLE (70658-126-31) ",
"NDC11Code": "70658-0126-31",
"ProductNDC": "70658-126",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Creative Essences",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N"
},
{
"NDCCode": "71093-126-02",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71093-126-02) ",
"NDC11Code": "71093-0126-02",
"ProductNDC": "71093-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078042",
"LabelerName": "ACI Healthcare USA, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230930",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (light beige), and 1000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1- pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.) Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and croscarmellose sodium. In addition to the ingredients listed above, the 250 mg tablet contains Opadry II (Blue), the 500 mg tablet contains Opadry II (Yellow), the 750 mg tablet contains Opadry II (Flesh) and the 1000 mg tablet contains Opadry II (white). Opadry II (Blue) contains FD&C Blue #2, hypromellose, macrogol, polydextrose, titanium dioxide, and triacetin. Opadry II (Yellow) contains hypromellose, iron oxide yellow, macrogol, polydextrose, titanium dioxide, and triacetin. Opadry II (Flesh) contains hypromellose, iron oxide yellow, iron oxide red, macrogol, polydextrose, titanium dioxide, and triacetin. Opadry II (white) contains hypromellose, polyethylene glycol, polydextrose, titanium dioxide, and triacetin. Meets USP Dissolution Method: Test 3."
},
{
"NDCCode": "71610-126-60",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (71610-126-60) ",
"NDC11Code": "71610-0126-60",
"ProductNDC": "71610-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078787",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2018-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180822",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
"Description": "The active ingredient in gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each capsule contains the following inactive ingredients: corn starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains yellow iron oxide and 400 mg also contains yellow iron oxide and red iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "72578-126-14",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (72578-126-14) ",
"NDC11Code": "72578-0126-14",
"ProductNDC": "72578-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone",
"NonProprietaryName": "Ziprasidone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208988",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 Ziprasidone is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].",
"Description": "Ziprasidone capsule contains the active moiety, ziprasidone, in the form of ziprasidone hydrochloride salt. Ziprasidone is an atypical antipsychotic available as capsules (ziprasidone hydrochloride) for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. Ziprasidone capsules, USP contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2 benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The molecular formula is C21H21ClN4OS∙HCl∙H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate, USP is white to slightly pink powder; slightly soluble in methanol, methylene chloride, isopropyl alcohol and hot tetrahydrofuran, soluble in formic acid and practically insoluble in water and ethanol. Each capsule contains ziprasidone hydrochloride monohydrate 20 mg or 40 mg or 60 mg or 80 mg and inactive ingredients: gelatin, lactose monohydrate, magnesium stearate, pregelatinized starch (botanical source: maize), sodium lauryl sulfate, titanium dioxide, water, FD & C Blue 1 (20 mg, 40 mg and 80 mg) and FD & C Red 40 (20 mg, 40 mg and 80 mg). Additionally, capsule shells of 20 mg, 40 mg and 80 mg are imprinted with white pharmaceutical ink and capsule shells of 60 mg are imprinted with black pharmaceutical ink. The compositions of the black and white pharmaceutical ink are: potassium hydroxide, propylene glycol, shellac, titanium dioxide and ferrosoferric oxide (black pharmaceutical ink). FDA approved drug release test specifications differ from USP."
},
{
"NDCCode": "77598-126-02",
"PackageDescription": "60 mL in 1 BOTTLE (77598-126-02) ",
"NDC11Code": "77598-0126-02",
"ProductNDC": "77598-126",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allora",
"NonProprietaryName": "Sanitizing Gel",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Guangzhou Ouzhuang Biological Technology Co Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200515",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
}
]
}
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<NDCList>
<NDC>
<NDCCode>81279-126-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (81279-126-60) </PackageDescription>
<NDC11Code>81279-0126-60</NDC11Code>
<ProductNDC>81279-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219319</ApplicationNumber>
<LabelerName>Pangea Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules USP is gabapentin USP, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pKa 1of 3.7 and a pKa 2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin capsule contains 200 mg of gabapentin and the following inactive ingredients. Pregelatinized maize starch, talc, magnesium stearate, gelatin, titanium dioxide, red iron oxide. Ingredient of imprinting ink (TekPrint TMSB-6018 Blue Ink) are Shellac NF, Dehydrated Alcohol USP, Isopropyl Alcohol USP, Butyl Alcohol NF, Propylene Glycol USP, Strong Ammonia Solution NF, FD & C Blue # 2 Aluminum Lake. FDA approved dissolution test specifications differ from the USP.</Description>
</NDC>
<NDC>
<NDCCode>81279-117-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (81279-117-60) </PackageDescription>
<NDC11Code>81279-0117-60</NDC11Code>
<ProductNDC>81279-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone</ProprietaryName>
<NonProprietaryName>Dexamethasone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088149</ApplicationNumber>
<LabelerName>Pangea Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DEXAMETHASONE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergic states:Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.</IndicationAndUsage>
<Description>Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α,-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. C 22H 29FO 5 MW 392.47. DEXLYT TM, for oral administration, contains 0.25 mgof dexamethasone. Each tablet contains the following inactive ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, stearic acid and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>81279-117-88</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (81279-117-88) </PackageDescription>
<NDC11Code>81279-0117-88</NDC11Code>
<ProductNDC>81279-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone</ProprietaryName>
<NonProprietaryName>Dexamethasone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088149</ApplicationNumber>
<LabelerName>Pangea Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DEXAMETHASONE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.</IndicationAndUsage>
<Description>Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α,-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. C 22H 29FO 5 MW 392.47. Each tablet, for oral administration, contains 0.25 mgof dexamethasone. Each tablet contains the following inactive ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, stearic acid and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>81279-121-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (81279-121-60) </PackageDescription>
<NDC11Code>81279-0121-60</NDC11Code>
<ProductNDC>81279-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bucapsol</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218628</ApplicationNumber>
<LabelerName>PANGEA PHARMACEUTICALS, LLC</LabelerName>
<SubstanceName>BUSPIRONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bucapsol TMcapsules 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 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 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, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 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. 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. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride for extended periods should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Bucapsol TMcapsules are antianxiety agents that are 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 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2∙HCl is represented by the following structural formula:. Bucapsol TMcapsules are supplied as capsules for oral administration. Bucapsol TMcapsules contains 5 mg, 7.5 mg, 10 mg, or 15 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.8 mg, 9.1 mg, and 13.7 mg of buspirone free base, respectively) in a hard gelatin shell. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The shell consists of black ink, gelatin, titanium dioxide, fd&c blue no. 1 (7.5 mg, 10 mg, and 15 mg), and black iron oxide (10 mg) and is imprinted with edible ink.</Description>
</NDC>
<NDC>
<NDCCode>81279-122-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (81279-122-60) </PackageDescription>
<NDC11Code>81279-0122-60</NDC11Code>
<ProductNDC>81279-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bucapsol</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218628</ApplicationNumber>
<LabelerName>PANGEA PHARMACEUTICALS, LLC</LabelerName>
<SubstanceName>BUSPIRONE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bucapsol TMcapsules 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 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 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, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 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. 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. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride for extended periods should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Bucapsol TMcapsules are antianxiety agents that are 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 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2∙HCl is represented by the following structural formula:. Bucapsol TMcapsules are supplied as capsules for oral administration. Bucapsol TMcapsules contains 5 mg, 7.5 mg, 10 mg, or 15 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.8 mg, 9.1 mg, and 13.7 mg of buspirone free base, respectively) in a hard gelatin shell. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The shell consists of black ink, gelatin, titanium dioxide, fd&c blue no. 1 (7.5 mg, 10 mg, and 15 mg), and black iron oxide (10 mg) and is imprinted with edible ink.</Description>
</NDC>
<NDC>
<NDCCode>81279-123-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (81279-123-60) </PackageDescription>
<NDC11Code>81279-0123-60</NDC11Code>
<ProductNDC>81279-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bucapsol</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218628</ApplicationNumber>
<LabelerName>PANGEA PHARMACEUTICALS, LLC</LabelerName>
<SubstanceName>BUSPIRONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bucapsol TMcapsules 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 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 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, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 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. 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. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride for extended periods should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Bucapsol TMcapsules are antianxiety agents that are 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 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2∙HCl is represented by the following structural formula:. Bucapsol TMcapsules are supplied as capsules for oral administration. Bucapsol TMcapsules contains 5 mg, 7.5 mg, 10 mg, or 15 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.8 mg, 9.1 mg, and 13.7 mg of buspirone free base, respectively) in a hard gelatin shell. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The shell consists of black ink, gelatin, titanium dioxide, fd&c blue no. 1 (7.5 mg, 10 mg, and 15 mg), and black iron oxide (10 mg) and is imprinted with edible ink.</Description>
</NDC>
<NDC>
<NDCCode>81279-124-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (81279-124-60) </PackageDescription>
<NDC11Code>81279-0124-60</NDC11Code>
<ProductNDC>81279-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bucapsol</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218628</ApplicationNumber>
<LabelerName>PANGEA PHARMACEUTICALS, LLC</LabelerName>
<SubstanceName>BUSPIRONE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bucapsol TMcapsules 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 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 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, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 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. 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. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride for extended periods should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Bucapsol TMcapsules are antianxiety agents that are 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 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2∙HCl is represented by the following structural formula:. Bucapsol TMcapsules are supplied as capsules for oral administration. Bucapsol TMcapsules contains 5 mg, 7.5 mg, 10 mg, or 15 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.8 mg, 9.1 mg, and 13.7 mg of buspirone free base, respectively) in a hard gelatin shell. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The shell consists of black ink, gelatin, titanium dioxide, fd&c blue no. 1 (7.5 mg, 10 mg, and 15 mg), and black iron oxide (10 mg) and is imprinted with edible ink.</Description>
</NDC>
<NDC>
<NDCCode>81279-129-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (81279-129-60) </PackageDescription>
<NDC11Code>81279-0129-60</NDC11Code>
<ProductNDC>81279-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyproheptadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyproheptadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261012</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212491</ApplicationNumber>
<LabelerName>PANGEA PHARMACEUTICALS, LLC</LabelerName>
<SubstanceName>CYPROHEPTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>81279-130-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (81279-130-60) </PackageDescription>
<NDC11Code>81279-0130-60</NDC11Code>
<ProductNDC>81279-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ursolign</ProprietaryName>
<NonProprietaryName>Ursodiol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210344</ApplicationNumber>
<LabelerName>Pangea Pharmaceuticals, LLC</LabelerName>
<SubstanceName>URSODIOL</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bile Acid [EPC], Bile Acids and Salts [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>URSOLIGNTM is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of URSOLIGNTM beyond 24 months is not established. URSOLIGNTM is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.</IndicationAndUsage>
<Description>URSOLIGNTM is a bile acid available as 150 mg capsules suitable for oral administration. URSOLIGNTM is ursodiol, USP (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white or almost white crystalline powder freely soluble in alcohol; slightly soluble in acetone and in methylene chloride; very slightly soluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below. Ursodiol Capsules 150 mg contains following inactive ingredients: Corn starch, colloidal silicon dioxide, magnesium stearate, talc, citric acid, titanium dioxide, gelatin and glycine. The imprinting ink contains shellac, black iron oxide and traces of potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>16571-126-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16571-126-06) </PackageDescription>
<NDC11Code>16571-0126-06</NDC11Code>
<ProductNDC>16571-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
<NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204721</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
<Description>Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7 , and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, opadry white 03A18585 [hypromellose, purified stearic acid, titanium dioxide, microcrystalline cellulose].</Description>
</NDC>
<NDC>
<NDCCode>16590-126-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16590-126-60)</PackageDescription>
<NDC11Code>16590-0126-60</NDC11Code>
<ProductNDC>16590-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075682</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.</IndicationAndUsage>
<Description>IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water(less than 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21130-126-72</NDCCode>
<PackageDescription>60 TABLET, CHEWABLE in 1 BOTTLE (21130-126-72) </PackageDescription>
<NDC11Code>21130-0126-72</NDC11Code>
<ProductNDC>21130-126</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Antacid</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24979-126-18</NDCCode>
<PackageDescription>60 VIAL, SINGLE-USE in 1 CARTON (24979-126-18) / .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>24979-0126-18</NDC11Code>
<ProductNDC>24979-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclosporine</ProprietaryName>
<NonProprietaryName>Cyclosporine</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20260327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209064</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>CYCLOSPORINE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclosporine ophthalmic emulsion 0.05% is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.</IndicationAndUsage>
<Description>Cyclosporine ophthalmic emulsion 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure. Structural Formula. Formula: C62H111N11O12 Mol. Wt.: 1202.6. Cyclosporine is a fine white powder. Cyclosporine ophthalmic emulsion 0.05% appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5-8.0. Each mL of cyclosporine ophthalmic emulsion 0.05% contains: Active: cyclosporine 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer copolymer type A; purified water; and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>27241-126-02</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-126-02) </PackageDescription>
<NDC11Code>27241-0126-02</NDC11Code>
<ProductNDC>27241-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210054</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine extended-release tablets are available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an molecular formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white powder. Ranolazine is soluble in methanol; sparingly soluble in acetonitrile; slightly soluble in isopropyl alcohol and very slightly soluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: Hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer (sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose, polyethylene glycol and sodium hydroxide. The color coating contains titanium dioxide, polyvinyl alcohol, talc, hypromellose, polyethylene glycol, Iron Oxide Yellow, and Iron Oxide Red.</Description>
</NDC>
<NDC>
<NDCCode>35356-126-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-126-60)</PackageDescription>
<NDC11Code>35356-0126-60</NDC11Code>
<ProductNDC>35356-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Theophylline</ProprietaryName>
<NonProprietaryName>Theophylline</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089808</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>THEOPHYLLINE ANHYDROUS</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Methylxanthine [EPC],Xanthines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>43063-126-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-126-60) </PackageDescription>
<NDC11Code>43063-0126-60</NDC11Code>
<ProductNDC>43063-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078332</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>3.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: : 1 mild to severe chronic heart failure ( 1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43744-126-60</NDCCode>
<PackageDescription>750 g in 1 DRUM (43744-126-60)</PackageDescription>
<NDC11Code>43744-0126-60</NDC11Code>
<ProductNDC>43744-126</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Carbimazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110707</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>CARBIMAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52959-126-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (52959-126-60)</PackageDescription>
<NDC11Code>52959-0126-60</NDC11Code>
<ProductNDC>52959-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040256</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis, 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis, 4 Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis, 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis, 7 Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus, 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg.</Description>
</NDC>
<NDC>
<NDCCode>53045-126-60</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (53045-126-60) </PackageDescription>
<NDC11Code>53045-0126-60</NDC11Code>
<ProductNDC>53045-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iolite-s</ProprietaryName>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20210104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Dharma Research, Inc.</LabelerName>
<SubstanceName>BENZOCAINE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59115-126-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (59115-126-60)</PackageDescription>
<NDC11Code>59115-0126-60</NDC11Code>
<ProductNDC>59115-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091185</ApplicationNumber>
<LabelerName>Hikma Pharmaceutical</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>61919-126-72</NDCCode>
<PackageDescription>120 BOTTLE in 1 BOTTLE (61919-126-72) > 90 BOTTLE in 1 BOTTLE (61919-126-90) > 60 BOTTLE in 1 BOTTLE (61919-126-60) > 30 TABLET, FILM COATED in 1 BOTTLE (61919-126-30)</PackageDescription>
<NDC11Code>61919-0126-72</NDC11Code>
<ProductNDC>61919-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>Direct Rx</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>64950-126-06</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (64950-126-06) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>64950-0126-06</NDC11Code>
<ProductNDC>64950-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Halog</ProprietaryName>
<NonProprietaryName>Halcinonide Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260113</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017556</ApplicationNumber>
<LabelerName>Genus Lifesciences Inc.</LabelerName>
<SubstanceName>HALCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HALOG (Halcinonide Cream, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. Halcinonide, USP is designated chemically as 21-Chloro-9-fluoro-11β, 16α, 17-trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. Graphic formula. Each gram of 0.1% HALOG (Halcinonide Cream, USP) contains 1 mg halcinonide, USP in a specially formulated cream base consisting of cetyl alcohol, dimethicone 350, glyceryl monostearate, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>66267-126-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (66267-126-60) </PackageDescription>
<NDC11Code>66267-0126-60</NDC11Code>
<ProductNDC>66267-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoprofen</ProprietaryName>
<NonProprietaryName>Ketoprofen</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073517</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>KETOPROFEN</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>2020-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69452-126-19</NDCCode>
<PackageDescription>90 PACKET in 1 CARTON (69452-126-19) / 1 POWDER, FOR SUSPENSION in 1 PACKET (69452-126-60) </PackageDescription>
<NDC11Code>69452-0126-19</NDC11Code>
<ProductNDC>69452-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sevelamer Carbonate</ProprietaryName>
<NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209374</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>SEVELAMER CARBONATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sevelamer carbonate for oral suspension is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
<Description>The active ingredient in sevelamer carbonate for oral suspension is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate-binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine- co-N,N’-diallyl-1,3diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water and other solvents. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Carbonate. a, b = number of primary amine groups a + b = 9. c = number of cross-linking groups c = 1. m = large number to indicate extended polymer network. Each packet of sevelamer carbonate powder contains 0.8 g or 2.4 g of sevelamer carbonate on an anhydrous basis. The inactive ingredients are lemon flavor, propylene glycol alginate, silicon dioxide, sodium chloride, and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>70010-126-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-126-06) </PackageDescription>
<NDC11Code>70010-0126-06</NDC11Code>
<ProductNDC>70010-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218385</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70658-126-31</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (70658-126-31) </PackageDescription>
<NDC11Code>70658-0126-31</NDC11Code>
<ProductNDC>70658-126</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Creative Essences</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71093-126-02</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71093-126-02) </PackageDescription>
<NDC11Code>71093-0126-02</NDC11Code>
<ProductNDC>71093-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078042</ApplicationNumber>
<LabelerName>ACI Healthcare USA, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (light beige), and 1000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1- pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.) Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and croscarmellose sodium. In addition to the ingredients listed above, the 250 mg tablet contains Opadry II (Blue), the 500 mg tablet contains Opadry II (Yellow), the 750 mg tablet contains Opadry II (Flesh) and the 1000 mg tablet contains Opadry II (white). Opadry II (Blue) contains FD&C Blue #2, hypromellose, macrogol, polydextrose, titanium dioxide, and triacetin. Opadry II (Yellow) contains hypromellose, iron oxide yellow, macrogol, polydextrose, titanium dioxide, and triacetin. Opadry II (Flesh) contains hypromellose, iron oxide yellow, iron oxide red, macrogol, polydextrose, titanium dioxide, and triacetin. Opadry II (white) contains hypromellose, polyethylene glycol, polydextrose, titanium dioxide, and triacetin. Meets USP Dissolution Method: Test 3.</Description>
</NDC>
<NDC>
<NDCCode>71610-126-60</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (71610-126-60) </PackageDescription>
<NDC11Code>71610-0126-60</NDC11Code>
<ProductNDC>71610-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078787</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each capsule contains the following inactive ingredients: corn starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains yellow iron oxide and 400 mg also contains yellow iron oxide and red iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72578-126-14</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (72578-126-14) </PackageDescription>
<NDC11Code>72578-0126-14</NDC11Code>
<ProductNDC>72578-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone</ProprietaryName>
<NonProprietaryName>Ziprasidone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208988</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 Ziprasidone is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>Ziprasidone capsule contains the active moiety, ziprasidone, in the form of ziprasidone hydrochloride salt. Ziprasidone is an atypical antipsychotic available as capsules (ziprasidone hydrochloride) for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. Ziprasidone capsules, USP contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2 benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The molecular formula is C21H21ClN4OS∙HCl∙H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate, USP is white to slightly pink powder; slightly soluble in methanol, methylene chloride, isopropyl alcohol and hot tetrahydrofuran, soluble in formic acid and practically insoluble in water and ethanol. Each capsule contains ziprasidone hydrochloride monohydrate 20 mg or 40 mg or 60 mg or 80 mg and inactive ingredients: gelatin, lactose monohydrate, magnesium stearate, pregelatinized starch (botanical source: maize), sodium lauryl sulfate, titanium dioxide, water, FD & C Blue 1 (20 mg, 40 mg and 80 mg) and FD & C Red 40 (20 mg, 40 mg and 80 mg). Additionally, capsule shells of 20 mg, 40 mg and 80 mg are imprinted with white pharmaceutical ink and capsule shells of 60 mg are imprinted with black pharmaceutical ink. The compositions of the black and white pharmaceutical ink are: potassium hydroxide, propylene glycol, shellac, titanium dioxide and ferrosoferric oxide (black pharmaceutical ink). FDA approved drug release test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>77598-126-02</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (77598-126-02) </PackageDescription>
<NDC11Code>77598-0126-02</NDC11Code>
<ProductNDC>77598-126</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allora</ProprietaryName>
<NonProprietaryName>Sanitizing Gel</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Guangzhou Ouzhuang Biological Technology Co Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
</NDCList>