{
"NDC": [
{
"NDCCode": "50114-5347-6",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (50114-5347-6) > 2.2 mL in 1 VIAL, GLASS",
"NDC11Code": "50114-5347-06",
"ProductNDC": "50114-5347",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinusin",
"NonProprietaryName": "Pulsatilla Vulgaris And Euphorbia Resinifera Resin And Luffa Opsilver Nitrateerculata Fruit And Mercuric Iodide And Sus Scrofa Nasal Mucosa And Silver Nitrate And Calcium Sulfide And Sinusitisinum",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20110706",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; PULSATILLA VULGARIS; SILVER NITRATE; SINUSITISINUM; SUS SCROFA NASAL MUCOSA",
"StrengthNumber": "10; 4; 6; 8; 2; 10; 13; 8",
"StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL",
"Status": "Deprecated",
"LastUpdate": "2015-06-26"
},
{
"NDCCode": "0093-5347-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5347-01) ",
"NDC11Code": "00093-5347-01",
"ProductNDC": "0093-5347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"ProprietaryNameSuffix": "(la)",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079031",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120716",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)].",
"Description": "Methylphenidate Hydrochloride Extended-Release Capsules contain methylphenidate hydrochloride, USP, a CNS stimulant. Methylphenidate Hydrochloride Extended-Release Capsules are an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each Methylphenidate Hydrochloride Extended-Release Capsule contains pellets, with half the dose as immediate-release and half as delayed-release, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in Methylphenidate Hydrochloride Extended-Release Capsules is methyl α-phenyl-2-piperidineacetate hydrochloride. Its structural formula is as follows. M.W. 269.77. Methylphenidate hydrochloride, USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each capsule, for oral administration, has the following inactive ingredients: ammonio methacrylate copolymer, black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze (modified), sugar spheres, talc, titanium dioxide and triethyl citrate. The 10 mg and 40 mg capsule shell contains FD&C blue no. 1, FD&C red no. 40 and FD&C yellow no. 6. The 30 mg capsule shell contains D&C red no. 33 and D&C yellow no. 10."
},
{
"NDCCode": "0591-5347-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-5347-01) ",
"NDC11Code": "00591-5347-01",
"ProductNDC": "0591-5347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Probenecid",
"NonProprietaryName": "Probenecid",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19830701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084442",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PROBENECID",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830701",
"SamplePackage": "N",
"IndicationAndUsage": "For treatment of the hyperuricemia associated with gout and gouty arthritis. As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given.",
"Description": "Probenecid, USP is a uricosuric and renal tubular transport blocking agent. Probenecid is the generic name for 4-[(dipropyl-amino)sulfonyl] benzoic acid. It has the following structural formula. C13H19NO4S M.W. 285.36. Probenecid, USP is a white or nearly white, fine, crystalline powder. Probenecid is soluble in dilute alkali, in alcohol, in chloroform, and in acetone; it is practically insoluble in water and in dilute acids. Probenecid tablets USP, 500 mg contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "0591-5347-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-5347-10) ",
"NDC11Code": "00591-5347-10",
"ProductNDC": "0591-5347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Probenecid",
"NonProprietaryName": "Probenecid",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19830701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084442",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PROBENECID",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830701",
"SamplePackage": "N",
"IndicationAndUsage": "For treatment of the hyperuricemia associated with gout and gouty arthritis. As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given.",
"Description": "Probenecid, USP is a uricosuric and renal tubular transport blocking agent. Probenecid is the generic name for 4-[(dipropyl-amino)sulfonyl] benzoic acid. It has the following structural formula. C13H19NO4S M.W. 285.36. Probenecid, USP is a white or nearly white, fine, crystalline powder. Probenecid is soluble in dilute alkali, in alcohol, in chloroform, and in acetone; it is practically insoluble in water and in dilute acids. Probenecid tablets USP, 500 mg contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "50090-5347-0",
"PackageDescription": "30 TABLET in 1 BOTTLE (50090-5347-0) ",
"NDC11Code": "50090-5347-00",
"ProductNDC": "50090-5347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202330",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone 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 relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 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.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 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 C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "50090-5347-1",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-5347-1) ",
"NDC11Code": "50090-5347-01",
"ProductNDC": "50090-5347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202330",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone 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 relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 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.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 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 C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "50090-5347-3",
"PackageDescription": "180 TABLET in 1 BOTTLE (50090-5347-3) ",
"NDC11Code": "50090-5347-03",
"ProductNDC": "50090-5347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202330",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone 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 relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 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.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 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 C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "50090-5347-4",
"PackageDescription": "45 TABLET in 1 BOTTLE (50090-5347-4) ",
"NDC11Code": "50090-5347-04",
"ProductNDC": "50090-5347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202330",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone 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 relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 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.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 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 C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "50090-5347-5",
"PackageDescription": "60 TABLET in 1 BOTTLE (50090-5347-5) ",
"NDC11Code": "50090-5347-05",
"ProductNDC": "50090-5347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202330",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone 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 relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 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.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 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 C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "54868-5347-0",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-5347-0)",
"NDC11Code": "54868-5347-00",
"ProductNDC": "54868-5347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paxilcr",
"ProprietaryNameSuffix": "Cr",
"NonProprietaryName": "Paroxetine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20050706",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020936",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "PAXIL CR is indicated for the treatment of major depressive disorder. The efficacy of PAXIL CR in the treatment of a major depressive episode was established in two 12-week controlled trials of outpatients whose diagnoses corresponded to the DSM-IV category of major depressive disorder (see CLINICAL PHARMACOLOGY: Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least 5 of the following 9 symptoms during the same 2-week period: Depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The antidepressant action of paroxetine in hospitalized depressed patients has not been adequately studied. PAXIL CR has not been systematically evaluated beyond 12 weeks in controlled clinical trials; however, the effectiveness of immediate-release paroxetine hydrochloride in maintaining a response in major depressive disorder for up to 1 year has been demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY: Clinical Trials). The physician who elects to use PAXIL CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "PAXIL CR (paroxetine hydrochloride) is an orally administered psychotropic drug with a chemical structure unrelated to other selective serotonin reuptake inhibitors or to tricyclic, tetracyclic, or other available antidepressant or antipanic agents. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Each enteric, film-coated, controlled-release tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 12.5 mg–yellow, 25 mg–pink, 37.5 mg–blue. One layer of the tablet consists of a degradable barrier layer and the other contains the active material in a hydrophilic matrix. Inactive ingredients consist of hypromellose, polyvinylpyrrolidone, lactose monohydrate, magnesium stearate, silicon dioxide, glyceryl behenate, methacrylic acid copolymer type C, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate, titanium dioxide, polyethylene glycols, and 1 or more of the following colorants: Yellow ferric oxide, red ferric oxide, D&C Red No. 30 aluminum lake, FD&C Yellow No. 6 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake."
},
{
"NDCCode": "50114-0104-6",
"PackageDescription": "10 AMPULE in 1 CARTON (50114-0104-6) > 2.2 mL in 1 AMPULE",
"NDC11Code": "50114-0104-06",
"ProductNDC": "50114-0104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tonsilla Compositum",
"NonProprietaryName": "Conium Maculatum Flowering Top, Solanum Dulcamara Top, Echinacea, Unspecified, Horse Chestnut,antimony Potassium Tartrate, Ascorbic Acid, Protortonia Cacti,galium Aparine,gentiana Lutea Root,geranium Robertianum, Pulsatilla Vulgaris,lactic Acid, L-, Sus Scrofa Adrenal Gland,sulfur,tribasic Calcium Phosphate,ferrosoferric Phosphate,sus Scrofa Umbilical Cord,pork Liver,sus Scrofa Hypothalamussus Scrofa Bone Marrow,sus Scrofa Spleen,sus Scrofa Adrenal Gland, Cortisone Acetate, Sus Scrofa Embryo,",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA, UNSPECIFIED; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; PULSATILLA VULGARIS; LACTIC ACID, L-; SULFUR; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; SUS SCROFA UMBILICAL CORD; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA BONE MARROW; SUS SCROFA SPLEEN; SUS SCROFA ADRENAL GLAND; CORTISONE ACETATE; SUS SCROFA EMBRYO; MERCURIUS SOLUBILIS; LEVOTHYROXINE; BARIUM CARBONATE; SUS SCROFA TONSIL",
"StrengthNumber": "4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 10; 10; 10; 10; 10; 10; 10; 13; 13; 13; 13; 13; 28; 28",
"StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; 1/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "50114-0110-6",
"PackageDescription": "10 VIAL in 1 CARTON (50114-0110-6) > 2.2 mL in 1 VIAL",
"NDC11Code": "50114-0110-06",
"ProductNDC": "50114-0110",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Solidago Compositum",
"NonProprietaryName": "Solidago Virgaurea Flowering Top And Baptisia Tinctoria Root And Berberis Vulgaris Root Bark And Equisetum Hyemale And Silver Nitrate And Lytta Vesicatoria And Capsicum And Cupric Sulfate And Clerodendranthus Spicatus Leaf And Chondrodendron Tomentosum Root And Smilax Regelii Root And Turpentine Oil And Apis Mellifera Venom And Agathosma Betulina Leaf And Human Coxsackievirus A And Mercuric Chloride And Sus Scrofa Urinary Bladder And Calcium Sulfide And Sodium Pyruvate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "SOLIDAGO VIRGAUREA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; EQUISETUM HYEMALE; SILVER NITRATE; LYTTA VESICATORIA; CAPSICUM; CUPRIC SULFATE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SMILAX REGELII ROOT; TURPENTINE OIL; APIS MELLIFERA VENOM; AGATHOSMA BETULINA LEAF; HUMAN COXSACKIEVIRUS A; MERCURIC CHLORIDE; SUS SCROFA URINARY BLADDER; CALCIUM SULFIDE; SODIUM PYRUVATE; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; ESCHERICHIA COLI; ARSENIC TRIOXIDE",
"StrengthNumber": "3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 13; 28",
"StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50114-0113-6",
"PackageDescription": "10 AMPULE in 1 CARTON (50114-0113-6) > 2.2 mL in 1 AMPULE",
"NDC11Code": "50114-0113-06",
"ProductNDC": "50114-0113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Echinacea Compositum Forte",
"NonProprietaryName": "Aconitum Napellus,echinacea, Unspecified, Arnica Montana Root, Baptisia Tinctoria Root ,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Euphorbia Resinifera Resin, Gelsemium Sempervirens Root, Phytolacca Americana Root, Silver Nitrate, Arsenic Trioxide, Mercuric Chloride, Phosphorus, Pulsatilla Vulgaris, Sulfur,thuja Occidentalis Leafy Twig,calcium Sulfide,lachesis Muta Venom,",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CORTISONE ACETATE; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; LACHESIS MUTA VENOM; MERCURIC CHLORIDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SILVER NITRATE; STAPHYLOCOCCUS EPIDERMIDIS; STAPHYLOCOCCUS HAEMOLYTICUS; STAPHYLOCOCCUS SIMULANS; STREPTOCOCCUS PYOGENES; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC",
"StrengthNumber": "5; 6; 10; 6; 8; 12; 15; 3; 8; 8; 8; 15; 12; 8; 10; 8; 10; 6; 10; 20; 20; 20; 20; 10; 10; 6; 12",
"StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-08-22"
},
{
"NDCCode": "50114-1032-6",
"PackageDescription": "10 VIAL in 1 CARTON (50114-1032-6) > 1.1 mL in 1 VIAL",
"NDC11Code": "50114-1032-06",
"ProductNDC": "50114-1032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cimicifuga-homaccord",
"NonProprietaryName": "Black Cohosh And Strontium Carbonate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "BLACK COHOSH; STRONTIUM CARBONATE",
"StrengthNumber": "4; 8",
"StrengthUnit": "[hp_X]/1.1mL; [hp_X]/1.1mL",
"Status": "Deprecated",
"LastUpdate": "2014-11-21"
},
{
"NDCCode": "50114-1034-6",
"PackageDescription": "10 VIAL in 1 CARTON (50114-1034-6) > 1.1 mL in 1 VIAL",
"NDC11Code": "50114-1034-06",
"ProductNDC": "50114-1034",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colocynthis-homaccord",
"NonProprietaryName": "Citrullus Colocynthis Fruit Pulp And Pseudognaphalium Obtusifolium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "CITRULLUS COLOCYNTHIS FRUIT PULP; PSEUDOGNAPHALIUM OBTUSIFOLIUM",
"StrengthNumber": "4; 3",
"StrengthUnit": "[hp_X]/1.1mL; [hp_X]/1.1mL",
"Status": "Deprecated",
"LastUpdate": "2015-06-26"
},
{
"NDCCode": "50114-1058-6",
"PackageDescription": "10 AMPULE in 1 CARTON (50114-1058-6) > 2.2 mL in 1 AMPULE",
"NDC11Code": "50114-1058-06",
"ProductNDC": "50114-1058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cor Compositum",
"NonProprietaryName": "Selenicereus Grandiflorus Stem, Arnica Montana Root, Nitroglycerin,potassium Carbonate, Kalmia Latifolia Leaf, Crataegus Laevigata Fruit,strychnos Ignatii Seed, Ranunculus Bulbosus, Lactic Acid, L-,arsenic Trioxide, Pork Heart, Fumaric Acid, Pork Liver,.alpha.-ketoglutaric Acid, Malic Acid, Sodium Diethyl Oxalacetate, Ouabain, Naja Naja Venom,spigelia Anthelmia And Activated Charcoal",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": ".ALPHA.-KETOGLUTARIC ACID; ACTIVATED CHARCOAL; ARNICA MONTANA ROOT; ARSENIC TRIOXIDE; CRATAEGUS LAEVIGATA FRUIT; FUMARIC ACID; KALMIA LATIFOLIA LEAF; LACTIC ACID, L-; MALIC ACID; NAJA NAJA VENOM; NITROGLYCERIN; OUABAIN; PORK HEART; PORK LIVER; POTASSIUM CARBONATE; RANUNCULUS BULBOSUS; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; STRYCHNOS IGNATII SEED",
"StrengthNumber": "8; 18; 4; 8; 6; 8; 4; 6; 8; 10; 4; 8; 8; 8; 4; 6; 3; 10; 6",
"StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2014-08-22"
},
{
"NDCCode": "50114-1064-6",
"PackageDescription": "10 VIAL in 1 CARTON (50114-1064-6) > 2.2 mL in 1 VIAL",
"NDC11Code": "50114-1064-06",
"ProductNDC": "50114-1064",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Euphorbium Compositum",
"NonProprietaryName": "Pulsatilla Vulgaris And Euphorbia Resinifera Resin And Luffa Operculata Fruit And Mercuric Iodide And Sus Scrofa Nasal Mucosa And Silver Nitrate And Calcium Sulfide And Sinusitisinum",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "PULSATILLA VULGARIS; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SUS SCROFA NASAL MUCOSA; SILVER NITRATE; CALCIUM SULFIDE; SINUSITISINUM",
"StrengthNumber": "2; 4; 6; 8; 8; 10; 10; 13",
"StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "50114-1080-6",
"PackageDescription": "10 AMPULE in 1 CARTON (50114-1080-6) > 2.2 mL in 1 AMPULE",
"NDC11Code": "50114-1080-06",
"ProductNDC": "50114-1080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thyreoidea Compositum",
"NonProprietaryName": "Lactic Acid, L-,viscum Album Fruiting Top,colchicum Autumnale Bulb,conium Maculatum Flowering Top,galium Aparine,fucus Vesiculosus, Sedum Acre,sempervivum Tectorum Leaf, Adenosine Cyclic Phosphate, Fumaric Acid, Alpha.-ketoglutaric Acid, Malic Acid, Sodium Diethyl Oxalacetate ,sus Scrofa Pineal Gland ,pulsatilla Vulgaris, Spongia Officinalis Skeleton, Roasted,thyroid, Porcine,calcium Fluoride, Sus Scrofa Umbilical Cord,pork Liver ,sus Scrofa Bone Marrow, Sus Scrofa Spleen,sus Scrofa Thymus, Cortisone",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": ".ALPHA.-KETOGLUTARIC ACID; ADENOSINE CYCLIC PHOSPHATE; CALCIUM FLUORIDE; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; FUCUS VESICULOSUS; FUMARIC ACID; GALIUM APARINE; LACTIC ACID, L-; MALIC ACID; PORK LIVER; PULSATILLA VULGARIS; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SPONGIA OFFICINALIS SKELETON, ROASTED; SULFUR; SUS SCROFA BONE MARROW; SUS SCROFA PINEAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; SUS SCROFA UMBILICAL CORD; THYROID, PORCINE; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "8; 8; 10; 4; 4; 28; 6; 8; 4; 3; 8; 10; 8; 6; 8; 8; 10; 10; 8; 10; 10; 10; 8; 3",
"StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-08-22"
},
{
"NDCCode": "50114-1084-6",
"PackageDescription": "10 AMPULE in 1 CARTON (50114-1084-6) > 2.2 mL in 1 AMPULE",
"NDC11Code": "50114-1084-06",
"ProductNDC": "50114-1084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viscum Compositum Medium",
"NonProprietaryName": "Viscum Album Fruiting Top, Adenosine Cyclic Phosphate, And Mercurous Iodide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; MERCUROUS IODIDE; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "8; 10; 1",
"StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL",
"Status": "Deprecated",
"LastUpdate": "2014-08-22"
},
{
"NDCCode": "50114-1094-6",
"PackageDescription": "10 VIAL in 1 CARTON (50114-1094-6) > 1.1 mL in 1 VIAL",
"NDC11Code": "50114-1094-06",
"ProductNDC": "50114-1094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neuralgo-rheum",
"NonProprietaryName": "Pseudognaphalium Obtusifolium And Causticum And Colchicum Autumnale Bulb And Citrullus Colocynthis Fruit Pulp And Iron And Lithium Benzoate And Toxicodendron Pubescens Leaf And Filipendula Ulmaria Roo",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20120117",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; FILIPENDULA ULMARIA ROOT; IRON; LITHIUM BENZOATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 6; 10",
"StrengthUnit": "[hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL",
"Status": "Deprecated",
"LastUpdate": "2014-09-05"
},
{
"NDCCode": "50114-1120-6",
"PackageDescription": "10 VIAL in 1 CARTON (50114-1120-6) > 2.2 mL in 1 VIAL",
"NDC11Code": "50114-1120-06",
"ProductNDC": "50114-1120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Traumeel",
"NonProprietaryName": "Arnica Montana Root And Atropa Belladonna And Aconitum Napellus And Hypericum Perforatum And Calendula Officinalis Flowering Top And Matricaria Recutita And Achillea Millefolium And Calcium Sulfide And Comfrey Root And Bellis Perennis And Mercurius Solubilis And Echinacea, Unspecified And Echinacea Purpurea And Hamamelis Virginiana Root Bark/stem Bark",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS",
"StrengthNumber": "3; 3; 3; 3; 2; 6; 2; 6; 2; 2; 1; 3; 3; 6",
"StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL",
"Status": "Deprecated",
"LastUpdate": "2014-08-29"
},
{
"NDCCode": "50114-1122-6",
"PackageDescription": "10 AMPULE in 1 CARTON (50114-1122-6) > 1.1 mL in 1 AMPULE",
"NDC11Code": "50114-1122-06",
"ProductNDC": "50114-1122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vertigoheel",
"NonProprietaryName": "Anamirta Cocculus Seed, Conium Maculatum Flowering Top, Ambergris, Kerosene",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; AMBERGRIS; KEROSENE",
"StrengthNumber": "3; 2; 5; 7",
"StrengthUnit": "[hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "50114-1164-6",
"PackageDescription": "10 AMPULE in 1 CARTON (50114-1164-6) > 2.2 mL in 1 AMPULE",
"NDC11Code": "50114-1164-06",
"ProductNDC": "50114-1164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thalamus Compositum",
"NonProprietaryName": "Adenosine Cyclic Phosphate, Sus Scrofa Pineal Gland, Sus Scrofa Thalamus Lateral Geniculate Nucleus, Sus Scrofa Adrenal Gland And Viscum Album Fruiting Top",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "6; 5; 8; 8; 10",
"StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; 1/2.2mL",
"Status": "Deprecated",
"LastUpdate": "2014-08-22"
},
{
"NDCCode": "50114-1216-6",
"PackageDescription": "10 VIAL in 1 CARTON (50114-1216-6) > 1.1 mL in 1 VIAL",
"NDC11Code": "50114-1216-06",
"ProductNDC": "50114-1216",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chelidonium Homaccord",
"NonProprietaryName": "Chelidonium Majus And Atropa Belladonna",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "ATROPA BELLADONNA; CHELIDONIUM MAJUS",
"StrengthNumber": "10; 10",
"StrengthUnit": "[hp_X]/1.1mL; [hp_X]/1.1mL",
"Status": "Deprecated",
"LastUpdate": "2014-11-21"
},
{
"NDCCode": "50114-1286-6",
"PackageDescription": "10 VIAL in 1 CARTON (50114-1286-6) > 1.1 mL in 1 VIAL",
"NDC11Code": "50114-1286-06",
"ProductNDC": "50114-1286",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Histamin",
"NonProprietaryName": "Histamine Dihydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "HISTAMINE DIHYDROCHLORIDE",
"StrengthNumber": "12",
"StrengthUnit": "[hp_X]/1.1mL",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "50114-1350-6",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (50114-1350-6)",
"NDC11Code": "50114-1350-06",
"ProductNDC": "50114-1350",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neurexan",
"NonProprietaryName": "Avena Sativa Flowering Top, Passiflora Incarnata Top, Zinc Valerate Dihydrate And Arabica Coffee Bean",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110705",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; PASSIFLORA INCARNATA TOP; ZINC VALERATE DIHYDRATE",
"StrengthNumber": "12; 2; 2; 4",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2014-08-29"
},
{
"NDCCode": "50114-4041-6",
"PackageDescription": "15 TABLET in 1 BOTTLE (50114-4041-6)",
"NDC11Code": "50114-4041-06",
"ProductNDC": "50114-4041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Discus Compositum Rx",
"NonProprietaryName": "Pseudognaphalium Obtusifolium And Berberis Vulgaris Root Bark And Black Cohosh And Cinchona Officinalis Bark And Citrullus Colocynthis Fruit Pulp And Ledum Palustre Twig And Ranunculus Bulbosus And Horse Chestnut And Ascorbic Acid And Cupric Acetate And Potassium Carbonate And Nadide And Sodium Diethyl Oxalacetate And Niacinamide And Trinitrophenol And Pulsatilla Vulgaris And Pyridoxine Hydrochloride And Riboflavin And Claviceps Purpurea Sclerotium And Silicon Dioxide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080830",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": ".ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; ASCORBIC ACID; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; COENZYME A; CUPRIC ACETATE; GONORRHEAL URETHRAL SECRETION HUMAN; HORSE CHESTNUT; LEDUM PALUSTRE TWIG; MERCURIC OXIDE, YELLOW; NADIDE; NIACINAMIDE; POTASSIUM CARBONATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; RANUNCULUS BULBOSUS; RIBOFLAVIN; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA INTERVERTEBRAL DISC; SUS SCROFA UMBILICAL CORD; THIAMINE HYDROCHLORIDE; TRIBASIC CALCIUM PHOSPHATE; TRINITROPHENOL; ZINC",
"StrengthNumber": "8; 8; 6; 4; 4; 4; 4; 6; 10; 6; 18; 6; 4; 10; 6; 6; 6; 3; 6; 6; 4; 6; 10; 6; 10; 6; 28; 10; 10; 8; 10; 8; 10; 6; 10; 6; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-06-26"
},
{
"NDCCode": "50114-4500-6",
"PackageDescription": "10 VIAL in 1 CARTON (50114-4500-6) > 1.1 mL in 1 VIAL",
"NDC11Code": "50114-4500-06",
"ProductNDC": "50114-4500",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Engystol",
"NonProprietaryName": "Cynanchum Vincetoxicum Root And Sulfur",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "CYNANCHUM VINCETOXICUM ROOT; SULFUR",
"StrengthNumber": "6; 4",
"StrengthUnit": "[hp_X]/1.1mL; [hp_X]/1.1mL",
"Status": "Deprecated",
"LastUpdate": "2015-06-26"
},
{
"NDCCode": "50114-5115-6",
"PackageDescription": "10 VIAL in 1 CARTON (50114-5115-6) > 1.1 mL in 1 VIAL",
"NDC11Code": "50114-5115-06",
"ProductNDC": "50114-5115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Belladonna Homaccord",
"NonProprietaryName": "Atropa Belladonna And Echinacea, Unspecified",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED",
"StrengthNumber": "4; 10",
"StrengthUnit": "[hp_X]/1.1mL; [hp_X]/1.1mL",
"Status": "Deprecated",
"LastUpdate": "2014-11-21"
},
{
"NDCCode": "50114-5120-6",
"PackageDescription": "10 AMPULE in 1 CARTON (50114-5120-6) > 2.2 mL in 1 AMPULE",
"NDC11Code": "50114-5120-06",
"ProductNDC": "50114-5120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cactus Compositum",
"NonProprietaryName": "Crataegus Laevigata Fruit, Selenicereus Grandiflorus Stem, Potassium Dichromate,spigelia Anthelmia, And Nitroglycerin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "CRATAEGUS LAEVIGATA FRUIT; NITROGLYCERIN; POTASSIUM DICHROMATE; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA",
"StrengthNumber": "2; 5; 5; 3; 5",
"StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2014-08-22"
}
]
}
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<NDCCode>0591-5347-01</NDCCode>
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<Description>Probenecid, USP is a uricosuric and renal tubular transport blocking agent. Probenecid is the generic name for 4-[(dipropyl-amino)sulfonyl] benzoic acid. It has the following structural formula. C13H19NO4S M.W. 285.36. Probenecid, USP is a white or nearly white, fine, crystalline powder. Probenecid is soluble in dilute alkali, in alcohol, in chloroform, and in acetone; it is practically insoluble in water and in dilute acids. Probenecid tablets USP, 500 mg contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide.</Description>
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<ProductNDC>0591-5347</ProductNDC>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>19830701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For treatment of the hyperuricemia associated with gout and gouty arthritis. As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given.</IndicationAndUsage>
<Description>Probenecid, USP is a uricosuric and renal tubular transport blocking agent. Probenecid is the generic name for 4-[(dipropyl-amino)sulfonyl] benzoic acid. It has the following structural formula. C13H19NO4S M.W. 285.36. Probenecid, USP is a white or nearly white, fine, crystalline powder. Probenecid is soluble in dilute alkali, in alcohol, in chloroform, and in acetone; it is practically insoluble in water and in dilute acids. Probenecid tablets USP, 500 mg contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide.</Description>
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<NDC11Code>50090-5347-00</NDC11Code>
<ProductNDC>50090-5347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
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<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone 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 relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 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.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 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 C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
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<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone 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 relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 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.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 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 C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
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<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone 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 relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 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.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 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 C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
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<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone 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 relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 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.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 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 C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
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<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone 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 relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 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.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 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 C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
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<IndicationAndUsage>PAXIL CR is indicated for the treatment of major depressive disorder. The efficacy of PAXIL CR in the treatment of a major depressive episode was established in two 12-week controlled trials of outpatients whose diagnoses corresponded to the DSM-IV category of major depressive disorder (see CLINICAL PHARMACOLOGY: Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least 5 of the following 9 symptoms during the same 2-week period: Depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The antidepressant action of paroxetine in hospitalized depressed patients has not been adequately studied. PAXIL CR has not been systematically evaluated beyond 12 weeks in controlled clinical trials; however, the effectiveness of immediate-release paroxetine hydrochloride in maintaining a response in major depressive disorder for up to 1 year has been demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY: Clinical Trials). The physician who elects to use PAXIL CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>PAXIL CR (paroxetine hydrochloride) is an orally administered psychotropic drug with a chemical structure unrelated to other selective serotonin reuptake inhibitors or to tricyclic, tetracyclic, or other available antidepressant or antipanic agents. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Each enteric, film-coated, controlled-release tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 12.5 mg–yellow, 25 mg–pink, 37.5 mg–blue. One layer of the tablet consists of a degradable barrier layer and the other contains the active material in a hydrophilic matrix. Inactive ingredients consist of hypromellose, polyvinylpyrrolidone, lactose monohydrate, magnesium stearate, silicon dioxide, glyceryl behenate, methacrylic acid copolymer type C, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate, titanium dioxide, polyethylene glycols, and 1 or more of the following colorants: Yellow ferric oxide, red ferric oxide, D&C Red No. 30 aluminum lake, FD&C Yellow No. 6 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake.</Description>
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<SubstanceName>CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA, UNSPECIFIED; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; PULSATILLA VULGARIS; LACTIC ACID, L-; SULFUR; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; SUS SCROFA UMBILICAL CORD; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA BONE MARROW; SUS SCROFA SPLEEN; SUS SCROFA ADRENAL GLAND; CORTISONE ACETATE; SUS SCROFA EMBRYO; MERCURIUS SOLUBILIS; LEVOTHYROXINE; BARIUM CARBONATE; SUS SCROFA TONSIL</SubstanceName>
<StrengthNumber>4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 10; 10; 10; 10; 10; 10; 10; 13; 13; 13; 13; 13; 28; 28</StrengthNumber>
<StrengthUnit>[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; 1/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-0110-6</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50114-0110-6) > 2.2 mL in 1 VIAL</PackageDescription>
<NDC11Code>50114-0110-06</NDC11Code>
<ProductNDC>50114-0110</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Solidago Compositum</ProprietaryName>
<NonProprietaryName>Solidago Virgaurea Flowering Top And Baptisia Tinctoria Root And Berberis Vulgaris Root Bark And Equisetum Hyemale And Silver Nitrate And Lytta Vesicatoria And Capsicum And Cupric Sulfate And Clerodendranthus Spicatus Leaf And Chondrodendron Tomentosum Root And Smilax Regelii Root And Turpentine Oil And Apis Mellifera Venom And Agathosma Betulina Leaf And Human Coxsackievirus A And Mercuric Chloride And Sus Scrofa Urinary Bladder And Calcium Sulfide And Sodium Pyruvate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>SOLIDAGO VIRGAUREA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; EQUISETUM HYEMALE; SILVER NITRATE; LYTTA VESICATORIA; CAPSICUM; CUPRIC SULFATE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SMILAX REGELII ROOT; TURPENTINE OIL; APIS MELLIFERA VENOM; AGATHOSMA BETULINA LEAF; HUMAN COXSACKIEVIRUS A; MERCURIC CHLORIDE; SUS SCROFA URINARY BLADDER; CALCIUM SULFIDE; SODIUM PYRUVATE; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; ESCHERICHIA COLI; ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 13; 28</StrengthNumber>
<StrengthUnit>[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50114-0113-6</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (50114-0113-6) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>50114-0113-06</NDC11Code>
<ProductNDC>50114-0113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Echinacea Compositum Forte</ProprietaryName>
<NonProprietaryName>Aconitum Napellus,echinacea, Unspecified, Arnica Montana Root, Baptisia Tinctoria Root ,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Euphorbia Resinifera Resin, Gelsemium Sempervirens Root, Phytolacca Americana Root, Silver Nitrate, Arsenic Trioxide, Mercuric Chloride, Phosphorus, Pulsatilla Vulgaris, Sulfur,thuja Occidentalis Leafy Twig,calcium Sulfide,lachesis Muta Venom,</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CORTISONE ACETATE; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; LACHESIS MUTA VENOM; MERCURIC CHLORIDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SILVER NITRATE; STAPHYLOCOCCUS EPIDERMIDIS; STAPHYLOCOCCUS HAEMOLYTICUS; STAPHYLOCOCCUS SIMULANS; STREPTOCOCCUS PYOGENES; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC</SubstanceName>
<StrengthNumber>5; 6; 10; 6; 8; 12; 15; 3; 8; 8; 8; 15; 12; 8; 10; 8; 10; 6; 10; 20; 20; 20; 20; 10; 10; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-08-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-1032-6</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50114-1032-6) > 1.1 mL in 1 VIAL</PackageDescription>
<NDC11Code>50114-1032-06</NDC11Code>
<ProductNDC>50114-1032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cimicifuga-homaccord</ProprietaryName>
<NonProprietaryName>Black Cohosh And Strontium Carbonate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>BLACK COHOSH; STRONTIUM CARBONATE</SubstanceName>
<StrengthNumber>4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-11-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-1034-6</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50114-1034-6) > 1.1 mL in 1 VIAL</PackageDescription>
<NDC11Code>50114-1034-06</NDC11Code>
<ProductNDC>50114-1034</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colocynthis-homaccord</ProprietaryName>
<NonProprietaryName>Citrullus Colocynthis Fruit Pulp And Pseudognaphalium Obtusifolium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>CITRULLUS COLOCYNTHIS FRUIT PULP; PSEUDOGNAPHALIUM OBTUSIFOLIUM</SubstanceName>
<StrengthNumber>4; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-06-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-1058-6</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (50114-1058-6) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>50114-1058-06</NDC11Code>
<ProductNDC>50114-1058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cor Compositum</ProprietaryName>
<NonProprietaryName>Selenicereus Grandiflorus Stem, Arnica Montana Root, Nitroglycerin,potassium Carbonate, Kalmia Latifolia Leaf, Crataegus Laevigata Fruit,strychnos Ignatii Seed, Ranunculus Bulbosus, Lactic Acid, L-,arsenic Trioxide, Pork Heart, Fumaric Acid, Pork Liver,.alpha.-ketoglutaric Acid, Malic Acid, Sodium Diethyl Oxalacetate, Ouabain, Naja Naja Venom,spigelia Anthelmia And Activated Charcoal</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>.ALPHA.-KETOGLUTARIC ACID; ACTIVATED CHARCOAL; ARNICA MONTANA ROOT; ARSENIC TRIOXIDE; CRATAEGUS LAEVIGATA FRUIT; FUMARIC ACID; KALMIA LATIFOLIA LEAF; LACTIC ACID, L-; MALIC ACID; NAJA NAJA VENOM; NITROGLYCERIN; OUABAIN; PORK HEART; PORK LIVER; POTASSIUM CARBONATE; RANUNCULUS BULBOSUS; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; STRYCHNOS IGNATII SEED</SubstanceName>
<StrengthNumber>8; 18; 4; 8; 6; 8; 4; 6; 8; 10; 4; 8; 8; 8; 4; 6; 3; 10; 6</StrengthNumber>
<StrengthUnit>[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-08-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-1064-6</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50114-1064-6) > 2.2 mL in 1 VIAL</PackageDescription>
<NDC11Code>50114-1064-06</NDC11Code>
<ProductNDC>50114-1064</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Euphorbium Compositum</ProprietaryName>
<NonProprietaryName>Pulsatilla Vulgaris And Euphorbia Resinifera Resin And Luffa Operculata Fruit And Mercuric Iodide And Sus Scrofa Nasal Mucosa And Silver Nitrate And Calcium Sulfide And Sinusitisinum</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>PULSATILLA VULGARIS; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SUS SCROFA NASAL MUCOSA; SILVER NITRATE; CALCIUM SULFIDE; SINUSITISINUM</SubstanceName>
<StrengthNumber>2; 4; 6; 8; 8; 10; 10; 13</StrengthNumber>
<StrengthUnit>[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-1080-6</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (50114-1080-6) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>50114-1080-06</NDC11Code>
<ProductNDC>50114-1080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thyreoidea Compositum</ProprietaryName>
<NonProprietaryName>Lactic Acid, L-,viscum Album Fruiting Top,colchicum Autumnale Bulb,conium Maculatum Flowering Top,galium Aparine,fucus Vesiculosus, Sedum Acre,sempervivum Tectorum Leaf, Adenosine Cyclic Phosphate, Fumaric Acid, Alpha.-ketoglutaric Acid, Malic Acid, Sodium Diethyl Oxalacetate ,sus Scrofa Pineal Gland ,pulsatilla Vulgaris, Spongia Officinalis Skeleton, Roasted,thyroid, Porcine,calcium Fluoride, Sus Scrofa Umbilical Cord,pork Liver ,sus Scrofa Bone Marrow, Sus Scrofa Spleen,sus Scrofa Thymus, Cortisone</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>.ALPHA.-KETOGLUTARIC ACID; ADENOSINE CYCLIC PHOSPHATE; CALCIUM FLUORIDE; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; FUCUS VESICULOSUS; FUMARIC ACID; GALIUM APARINE; LACTIC ACID, L-; MALIC ACID; PORK LIVER; PULSATILLA VULGARIS; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SPONGIA OFFICINALIS SKELETON, ROASTED; SULFUR; SUS SCROFA BONE MARROW; SUS SCROFA PINEAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; SUS SCROFA UMBILICAL CORD; THYROID, PORCINE; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>8; 8; 10; 4; 4; 28; 6; 8; 4; 3; 8; 10; 8; 6; 8; 8; 10; 10; 8; 10; 10; 10; 8; 3</StrengthNumber>
<StrengthUnit>[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-08-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-1084-6</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (50114-1084-6) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>50114-1084-06</NDC11Code>
<ProductNDC>50114-1084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viscum Compositum Medium</ProprietaryName>
<NonProprietaryName>Viscum Album Fruiting Top, Adenosine Cyclic Phosphate, And Mercurous Iodide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; MERCUROUS IODIDE; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>8; 10; 1</StrengthNumber>
<StrengthUnit>[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-08-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-1094-6</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50114-1094-6) > 1.1 mL in 1 VIAL</PackageDescription>
<NDC11Code>50114-1094-06</NDC11Code>
<ProductNDC>50114-1094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neuralgo-rheum</ProprietaryName>
<NonProprietaryName>Pseudognaphalium Obtusifolium And Causticum And Colchicum Autumnale Bulb And Citrullus Colocynthis Fruit Pulp And Iron And Lithium Benzoate And Toxicodendron Pubescens Leaf And Filipendula Ulmaria Roo</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120117</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; FILIPENDULA ULMARIA ROOT; IRON; LITHIUM BENZOATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 6; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-09-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-1120-6</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50114-1120-6) > 2.2 mL in 1 VIAL</PackageDescription>
<NDC11Code>50114-1120-06</NDC11Code>
<ProductNDC>50114-1120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Traumeel</ProprietaryName>
<NonProprietaryName>Arnica Montana Root And Atropa Belladonna And Aconitum Napellus And Hypericum Perforatum And Calendula Officinalis Flowering Top And Matricaria Recutita And Achillea Millefolium And Calcium Sulfide And Comfrey Root And Bellis Perennis And Mercurius Solubilis And Echinacea, Unspecified And Echinacea Purpurea And Hamamelis Virginiana Root Bark/stem Bark</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 2; 6; 2; 6; 2; 2; 1; 3; 3; 6</StrengthNumber>
<StrengthUnit>[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-08-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-1122-6</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (50114-1122-6) > 1.1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>50114-1122-06</NDC11Code>
<ProductNDC>50114-1122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vertigoheel</ProprietaryName>
<NonProprietaryName>Anamirta Cocculus Seed, Conium Maculatum Flowering Top, Ambergris, Kerosene</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; AMBERGRIS; KEROSENE</SubstanceName>
<StrengthNumber>3; 2; 5; 7</StrengthNumber>
<StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-1164-6</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (50114-1164-6) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>50114-1164-06</NDC11Code>
<ProductNDC>50114-1164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thalamus Compositum</ProprietaryName>
<NonProprietaryName>Adenosine Cyclic Phosphate, Sus Scrofa Pineal Gland, Sus Scrofa Thalamus Lateral Geniculate Nucleus, Sus Scrofa Adrenal Gland And Viscum Album Fruiting Top</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>6; 5; 8; 8; 10</StrengthNumber>
<StrengthUnit>[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; 1/2.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-08-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-1216-6</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50114-1216-6) > 1.1 mL in 1 VIAL</PackageDescription>
<NDC11Code>50114-1216-06</NDC11Code>
<ProductNDC>50114-1216</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chelidonium Homaccord</ProprietaryName>
<NonProprietaryName>Chelidonium Majus And Atropa Belladonna</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>ATROPA BELLADONNA; CHELIDONIUM MAJUS</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-11-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-1286-6</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50114-1286-6) > 1.1 mL in 1 VIAL</PackageDescription>
<NDC11Code>50114-1286-06</NDC11Code>
<ProductNDC>50114-1286</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Histamin</ProprietaryName>
<NonProprietaryName>Histamine Dihydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>HISTAMINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>[hp_X]/1.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-1350-6</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (50114-1350-6)</PackageDescription>
<NDC11Code>50114-1350-06</NDC11Code>
<ProductNDC>50114-1350</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neurexan</ProprietaryName>
<NonProprietaryName>Avena Sativa Flowering Top, Passiflora Incarnata Top, Zinc Valerate Dihydrate And Arabica Coffee Bean</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110705</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; PASSIFLORA INCARNATA TOP; ZINC VALERATE DIHYDRATE</SubstanceName>
<StrengthNumber>12; 2; 2; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-08-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-4041-6</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (50114-4041-6)</PackageDescription>
<NDC11Code>50114-4041-06</NDC11Code>
<ProductNDC>50114-4041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Discus Compositum Rx</ProprietaryName>
<NonProprietaryName>Pseudognaphalium Obtusifolium And Berberis Vulgaris Root Bark And Black Cohosh And Cinchona Officinalis Bark And Citrullus Colocynthis Fruit Pulp And Ledum Palustre Twig And Ranunculus Bulbosus And Horse Chestnut And Ascorbic Acid And Cupric Acetate And Potassium Carbonate And Nadide And Sodium Diethyl Oxalacetate And Niacinamide And Trinitrophenol And Pulsatilla Vulgaris And Pyridoxine Hydrochloride And Riboflavin And Claviceps Purpurea Sclerotium And Silicon Dioxide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080830</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>.ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; ASCORBIC ACID; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; COENZYME A; CUPRIC ACETATE; GONORRHEAL URETHRAL SECRETION HUMAN; HORSE CHESTNUT; LEDUM PALUSTRE TWIG; MERCURIC OXIDE, YELLOW; NADIDE; NIACINAMIDE; POTASSIUM CARBONATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; RANUNCULUS BULBOSUS; RIBOFLAVIN; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA INTERVERTEBRAL DISC; SUS SCROFA UMBILICAL CORD; THIAMINE HYDROCHLORIDE; TRIBASIC CALCIUM PHOSPHATE; TRINITROPHENOL; ZINC</SubstanceName>
<StrengthNumber>8; 8; 6; 4; 4; 4; 4; 6; 10; 6; 18; 6; 4; 10; 6; 6; 6; 3; 6; 6; 4; 6; 10; 6; 10; 6; 28; 10; 10; 8; 10; 8; 10; 6; 10; 6; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-06-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-4500-6</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50114-4500-6) > 1.1 mL in 1 VIAL</PackageDescription>
<NDC11Code>50114-4500-06</NDC11Code>
<ProductNDC>50114-4500</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Engystol</ProprietaryName>
<NonProprietaryName>Cynanchum Vincetoxicum Root And Sulfur</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>CYNANCHUM VINCETOXICUM ROOT; SULFUR</SubstanceName>
<StrengthNumber>6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-06-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-5115-6</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50114-5115-6) > 1.1 mL in 1 VIAL</PackageDescription>
<NDC11Code>50114-5115-06</NDC11Code>
<ProductNDC>50114-5115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Belladonna Homaccord</ProprietaryName>
<NonProprietaryName>Atropa Belladonna And Echinacea, Unspecified</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED</SubstanceName>
<StrengthNumber>4; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-11-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>50114-5120-6</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (50114-5120-6) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>50114-5120-06</NDC11Code>
<ProductNDC>50114-5120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cactus Compositum</ProprietaryName>
<NonProprietaryName>Crataegus Laevigata Fruit, Selenicereus Grandiflorus Stem, Potassium Dichromate,spigelia Anthelmia, And Nitroglycerin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>CRATAEGUS LAEVIGATA FRUIT; NITROGLYCERIN; POTASSIUM DICHROMATE; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA</SubstanceName>
<StrengthNumber>2; 5; 5; 3; 5</StrengthNumber>
<StrengthUnit>[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-08-22</LastUpdate>
</NDC>
</NDCList>