{
"NDC": [
{
"NDCCode": "27241-092-50",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (27241-092-50) ",
"NDC11Code": "27241-0092-50",
"ProductNDC": "27241-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207797",
"LabelerName": "Ajanta Pharma Limited",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170928",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild to moderate dementia of the Alzheimer’s type (1.1), 2 Mild to moderate dementia associated with Parkinson’s disease (1.2).",
"Description": "Rivastigmine tartrate, USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)- tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine tartrate capsules, USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides. Imprinting ink contains: shellac, propylene glycol, black iron oxide and potassium hydroxide. Rivastigmine tartrate capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "27241-092-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (27241-092-06) ",
"NDC11Code": "27241-0092-06",
"ProductNDC": "27241-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207797",
"LabelerName": "Ajanta Pharma Limited",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170928",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild to moderate dementia of the Alzheimer’s type (1.1), 2 Mild to moderate dementia associated with Parkinson’s disease (1.2).",
"Description": "Rivastigmine tartrate, USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)- tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine tartrate capsules, USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides. Imprinting ink contains: shellac, propylene glycol, black iron oxide and potassium hydroxide. Rivastigmine tartrate capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "27241-001-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (27241-001-50) ",
"NDC11Code": "27241-0001-50",
"ProductNDC": "27241-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201003",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140328",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone tablets are an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red."
},
{
"NDCCode": "27241-002-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (27241-002-50) ",
"NDC11Code": "27241-0002-50",
"ProductNDC": "27241-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201003",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140328",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone tablets are an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red."
},
{
"NDCCode": "27241-003-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (27241-003-50) ",
"NDC11Code": "27241-0003-50",
"ProductNDC": "27241-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201003",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140328",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone tablets are an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red."
},
{
"NDCCode": "27241-004-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (27241-004-50) ",
"NDC11Code": "27241-0004-50",
"ProductNDC": "27241-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201003",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140328",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone tablets are an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red."
},
{
"NDCCode": "27241-005-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (27241-005-50) ",
"NDC11Code": "27241-0005-50",
"ProductNDC": "27241-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201003",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140328",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone tablets are an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red."
},
{
"NDCCode": "27241-006-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (27241-006-50) ",
"NDC11Code": "27241-0006-50",
"ProductNDC": "27241-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201003",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140328",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone tablets are an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red."
},
{
"NDCCode": "27241-007-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (27241-007-50) ",
"NDC11Code": "27241-0007-50",
"ProductNDC": "27241-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201293",
"LabelerName": "Ajanta Pharma Limited",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Levetiracetam is indicated for adjunctive therapy in the treatment of: : 1 Partial onset seizures in patients one month of age and older with epilepsy (1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) .",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (yellow), 500 mg (orange), 750 mg (blue), and 1000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP, is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam tablets contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, povidone K30, colloidal silicon dioxide, talc, magnesium stearate, titanium dioxide, polyethylene glycol 3350, lecithin, polyvinyl alcohol, and additional agents listed below: 250 mg tablets: yellow iron oxide 500 mg tablets: iron oxide red, FD&C Yellow #6 aluminum lake 750 mg tablets: FD&C Blue #2 aluminum lake Meets USP Dissolution Method: Test 3."
},
{
"NDCCode": "27241-008-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (27241-008-50) ",
"NDC11Code": "27241-0008-50",
"ProductNDC": "27241-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201293",
"LabelerName": "Ajanta Pharma Limited",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Levetiracetam is indicated for adjunctive therapy in the treatment of: : 1 Partial onset seizures in patients one month of age and older with epilepsy (1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) .",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (yellow), 500 mg (orange), 750 mg (blue), and 1000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP, is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam tablets contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, povidone K30, colloidal silicon dioxide, talc, magnesium stearate, titanium dioxide, polyethylene glycol 3350, lecithin, polyvinyl alcohol, and additional agents listed below: 250 mg tablets: yellow iron oxide 500 mg tablets: iron oxide red, FD&C Yellow #6 aluminum lake 750 mg tablets: FD&C Blue #2 aluminum lake Meets USP Dissolution Method: Test 3."
},
{
"NDCCode": "27241-009-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (27241-009-50) ",
"NDC11Code": "27241-0009-50",
"ProductNDC": "27241-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201293",
"LabelerName": "Ajanta Pharma Limited",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Levetiracetam is indicated for adjunctive therapy in the treatment of: : 1 Partial onset seizures in patients one month of age and older with epilepsy (1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) .",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (yellow), 500 mg (orange), 750 mg (blue), and 1000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP, is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam tablets contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, povidone K30, colloidal silicon dioxide, talc, magnesium stearate, titanium dioxide, polyethylene glycol 3350, lecithin, polyvinyl alcohol, and additional agents listed below: 250 mg tablets: yellow iron oxide 500 mg tablets: iron oxide red, FD&C Yellow #6 aluminum lake 750 mg tablets: FD&C Blue #2 aluminum lake Meets USP Dissolution Method: Test 3."
},
{
"NDCCode": "27241-020-50",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-020-50) ",
"NDC11Code": "27241-0020-50",
"ProductNDC": "27241-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203957",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161018",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1) , 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2) , 3 Maintenance of healed duodenal ulcers in adults. (1.3) , 4 Treatment of active benign gastric ulcer in adults. (1.4) , 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8) , 9 Maintenance of healing of EE in adults. (1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10) .",
"Description": "The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, magnesium carbonate, talc, polyethylene glycol, hydroxypropyl cellulose, colloidal silicon dioxide, hypromellose, ferric oxide red, ferric oxide black, ferric oxide yellow, sodium bicarbonate, sodium lauryl sulfate. The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Lansoprazole delayed-release capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "27241-090-50",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (27241-090-50) ",
"NDC11Code": "27241-0090-50",
"ProductNDC": "27241-090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207797",
"LabelerName": "Ajanta Pharma Limited",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170928",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild to moderate dementia of the Alzheimer’s type (1.1), 2 Mild to moderate dementia associated with Parkinson’s disease (1.2).",
"Description": "Rivastigmine tartrate, USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)- tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine tartrate capsules, USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides. Imprinting ink contains: shellac, propylene glycol, black iron oxide and potassium hydroxide. Rivastigmine tartrate capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "27241-091-50",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (27241-091-50) ",
"NDC11Code": "27241-0091-50",
"ProductNDC": "27241-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207797",
"LabelerName": "Ajanta Pharma Limited",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170928",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild to moderate dementia of the Alzheimer’s type (1.1), 2 Mild to moderate dementia associated with Parkinson’s disease (1.2).",
"Description": "Rivastigmine tartrate, USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)- tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine tartrate capsules, USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides. Imprinting ink contains: shellac, propylene glycol, black iron oxide and potassium hydroxide. Rivastigmine tartrate capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "27241-093-50",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (27241-093-50) ",
"NDC11Code": "27241-0093-50",
"ProductNDC": "27241-093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207797",
"LabelerName": "Ajanta Pharma Limited",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170928",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild to moderate dementia of the Alzheimer’s type (1.1), 2 Mild to moderate dementia associated with Parkinson’s disease (1.2).",
"Description": "Rivastigmine tartrate, USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)- tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine tartrate capsules, USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides. Imprinting ink contains: shellac, propylene glycol, black iron oxide and potassium hydroxide. Rivastigmine tartrate capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "27241-109-50",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (27241-109-50) ",
"NDC11Code": "27241-0109-50",
"ProductNDC": "27241-109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209859",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180927",
"SamplePackage": "N",
"IndicationAndUsage": "Ranitidine capsules are indicated in: 1 Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year., 3 The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg two times a day., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.",
"Description": "Ranitidine hydrochloride (HCl) USP, is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine,hydrochloride. It has the following structure. The empirical formula is C13H22N4O3S HCl, representing a molecular weight of 350.8. Ranitidine HCl is a white to pale yellow crystalline, practically odorless powder. Very soluble in water, sparingly soluble in alcohol. Each capsule, for oral administration contains 168 mg or 336 mg of ranitidine hydrochloride equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: Silicon dioxide, corn starch, magnesium stearate, and sodium starch glycolate Type A corn. Each hard-gelatin capsule contains gelatin, titanium dioxide, FD&C Blue no. 1, FD&C Red no. 40, and FD&C Yellow no. 6. Imprinting ink contains: shellac, propylene glycol, ferrosoferric oxide and potassium hydroxide."
},
{
"NDCCode": "27241-140-42",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (27241-140-42) ",
"NDC11Code": "27241-0140-42",
"ProductNDC": "27241-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211012",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180924",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate, USP and other antibacterial drugs, doxycycline hyclate capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment:. Doxycycline, USP is indicated for the treatment of the following infections:. Doxycycline, USP is also indicated for the treatment of infections caused by the following gram-negative microorganisms. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline, USP is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: : 1 Escherichia coli., 2 Enterobacter aerogenes. , 3 Shigella species., 4 Acinetobacter species., 5 Respiratory tract infections caused by Haemophilus influenzae., 6 Respiratory tract and urinary tract infections caused by Klebsiella species. .",
"Description": "Doxycycline hyclate, USP is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules, USP for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate, USP is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: hard gelatin capsules (contains FD&C Blue 1, gelatin and titanium dioxide); magnesium stearate; microcrystalline cellulose; sodium lauryl sulfate. The black imprinting ink contains black iron oxide, propylene glycol, shellac, and potassium hydroxide."
},
{
"NDCCode": "27241-141-42",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (27241-141-42) ",
"NDC11Code": "27241-0141-42",
"ProductNDC": "27241-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211012",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180924",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate, USP and other antibacterial drugs, doxycycline hyclate capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment:. Doxycycline, USP is indicated for the treatment of the following infections:. Doxycycline, USP is also indicated for the treatment of infections caused by the following gram-negative microorganisms. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline, USP is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: : 1 Escherichia coli., 2 Enterobacter aerogenes. , 3 Shigella species., 4 Acinetobacter species., 5 Respiratory tract infections caused by Haemophilus influenzae., 6 Respiratory tract and urinary tract infections caused by Klebsiella species. .",
"Description": "Doxycycline hyclate, USP is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules, USP for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate, USP is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: hard gelatin capsules (contains FD&C Blue 1, gelatin and titanium dioxide); magnesium stearate; microcrystalline cellulose; sodium lauryl sulfate. The black imprinting ink contains black iron oxide, propylene glycol, shellac, and potassium hydroxide."
},
{
"NDCCode": "27241-249-49",
"PackageDescription": "50 mL in 1 BOTTLE (27241-249-49) ",
"NDC11Code": "27241-0249-49",
"ProductNDC": "27241-249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217529",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220425",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine for oral suspension is indicated in adults for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy., 5 treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias)., 6 reduction of the risk of duodenal ulcer recurrence.",
"Description": "The active ingredient in famotidine for oral suspension USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45 Its structural formula is. Each 5 mL of famotidine for oral suspension USP when prepared as directed contains 40 mg of famotidine USP and the following inactive ingredients: citric acid monohydrate, flavors (cherry, banana and peppermint), powdered cellulose, sucrose, sucralose, xanthan gum. Added as preservatives are methylparaben sodium, propylparaben sodium, and sodium benzoate. Famotidine USP is a white to pale yellow crystalline powder that is freely soluble in dimethyl formamide, glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate."
},
{
"NDCCode": "11489-092-01",
"PackageDescription": "1 JAR in 1 CARTON (11489-092-01) > 50 g in 1 JAR",
"NDC11Code": "11489-0092-01",
"ProductNDC": "11489-092",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No7 Protect And Perfect Intense Day Cream Spf 15",
"NonProprietaryName": "Avobenzone,octisalate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150707",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BCM Ltd",
"SubstanceName": "AVOBENZONE; OCTOCRYLENE; OCTISALATE",
"StrengthNumber": "1.5; 2; 1",
"StrengthUnit": "g/50g; g/50g; g/50g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "41250-092-50",
"PackageDescription": "50 LOZENGE in 1 BAG (41250-092-50) ",
"NDC11Code": "41250-0092-50",
"ProductNDC": "41250-092",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Herbal Cough Drop",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20160512",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Meijer Distribution Inc.",
"SubstanceName": "MENTHOL",
"StrengthNumber": "4.8",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160512",
"SamplePackage": "N"
},
{
"NDCCode": "46672-092-50",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (46672-092-50) ",
"NDC11Code": "46672-0092-50",
"ProductNDC": "46672-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040846",
"LabelerName": "Mikart, LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "2.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100609",
"SamplePackage": "N"
},
{
"NDCCode": "47682-092-33",
"PackageDescription": "50 PACKET in 1 BOX (47682-092-33) > 2 TABLET, CHEWABLE in 1 PACKET",
"NDC11Code": "47682-0092-33",
"ProductNDC": "47682-092",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi First Plus Antacid",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20081230",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Unifirst First Aid Corporation",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "420",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20081230",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. relieves: 1 acid indigestion, 2 sour stomach, 3 heartburn, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "53747-092-00",
"PackageDescription": "1 BAG in 1 DRUM (53747-092-00) / 50 kg in 1 BAG",
"NDC11Code": "53747-0092-00",
"ProductNDC": "53747-092",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ticagrelor",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190326",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Unichem Laboratories Limited, India",
"SubstanceName": "TICAGRELOR",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-12-12",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "26-MAR-19"
},
{
"NDCCode": "54575-092-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (54575-092-50)",
"NDC11Code": "54575-0092-50",
"ProductNDC": "54575-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Meadow Fescue Grass Pollen",
"NonProprietaryName": "Festuca Elatior Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19970529",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101381",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "FESTUCA PRATENSIS POLLEN",
"StrengthNumber": "100000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Standardized grass pollen extracts are used for the diagnosis and treatment of allergic disease to grass pollen. The standardized (Bioequivalent Allergy Unit) extract in these vials is designed primarily for the physician equipped to prepare dilutions and mixtures as required. STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/ml ARE NOT INTERCHANGEABLE WITH GRASS POLLEN EXTRACTS LABELED IN AU/ml OR WITH NON-STANDARDIZED (WEIGHT/VOLUME) GRASS POLLEN EXTRACTS. Patients being switched from other types of extracts to Allergy Laboratories should have their dose adjusted. Diagnosis of allergic disease to these grasses is made through a combined medical history sufficiently complete to identify allergic symptoms to grass pollen and identification of grass allergy by diagnostic skin testing. It is recommended that diagnostic skin testing (scratch or puncture) be performed with 10,000 BAU/ml grass pollen extracts before testing with 100,000 BAU/ml grass pollen extracts. 10,000 BAU/mL and 100,000 BAU/ml grass pollen extracts for immunotherapy are available for previously treated patients to facilitate dose selection for safe switching from non-standardized to standardized extracts. Patients being treated with grass pollen extracts for the first time can be initially immunized with dilutions prepared from the 10,000 BAU/ml extract (see Dosage and Administration). 100,000 BAU/ml grass pollen extract can be administered if the patient tolerates the 10,000 BAU/ml extract. Grass pollen immunotherapy is intended for patients whose grass allergic symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5).",
"Description": "Standardized grass pollen extracts labeled in BAU/ml are not interchangeable with grass pollen extracts labeled in AU/ml or with non-standardized grass pollen extracts. The recommended route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Do not inject intravenously. The extract is sterile and contains 50% (v/v) glycerin as a preservative. Standardized grass pollen extracts are available in both 10,000 BAU/ml and 100,000 BAU/ml potencies, except for Bermuda which is only available in 10,000 BAU/ml. The source material of the standardized grass extracts are the grass pollens. The 100,000 BAU/ml grass pollen extracts are prepared by extracting pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 100,000 BAU/ml. The 10,000 BAU/ml grass pollen extracts are prepared by dilution of the 100,000 BAU/ml grass pollen extracts. The 10,000 BAU/ml Bermuda grass pollen extract is prepared by extracting Bermuda grass pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 10,000 BAU/ml. The potency (in Bioequivalent Allergy Units per ml or BAU/ml) of standardized grass pollen extracts is determined by an in-vitro ELISA Competition assay (1) against CBER reference extracts and CBER reference serum pools distributed by the Center for Biologics Evaluation and Research, U S Food and Drug Administration. Potency based on Bioequivalent Allergy Units (BAU/ml) is printed on the label. FDA reference grass pollen extracts were assigned potency designations based on quantitative skin testing (2). The FDA reference extracts which can be diluted 1:500,000 fold intradermally to produce a sum of erythema diameter response of 50mm in highly puncture reactive subjects have been assigned 10,000 BAU/ml. References which can be diluted 1:5,000,000 fold intraderrnally to produce a sum of erythema diameter response of 50mm have been assigned 100,000 BAU/ml."
},
{
"NDCCode": "57344-092-03",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (57344-092-03) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "57344-0092-03",
"ProductNDC": "57344-092",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121213",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "AAA Pharmaceutical, Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20121213",
"SamplePackage": "N"
},
{
"NDCCode": "69584-092-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (69584-092-50) ",
"NDC11Code": "69584-0092-50",
"ProductNDC": "69584-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075388",
"LabelerName": "Oxford Pharmaceuticals, LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200727",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP 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, USP is supplied as tablets for oral administration containing 5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, and 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 and 30-mg tablets are provided in the adjustable dosage tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15-mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30-mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride, USP tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A)."
},
{
"NDCCode": "69766-092-01",
"PackageDescription": "50 kg in 1 DRUM (69766-092-01) ",
"NDC11Code": "69766-0092-01",
"ProductNDC": "69766-092",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20201211",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "MSN Life Sciences Private Limited",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-12-14",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "11-DEC-20"
},
{
"NDCCode": "71919-092-09",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-092-09) ",
"NDC11Code": "71919-0092-09",
"ProductNDC": "71919-092",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Asarum Europaeum",
"NonProprietaryName": "Asarum Europaeum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20091120",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ASARUM EUROPAEUM",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20091120",
"SamplePackage": "N"
},
{
"NDCCode": "71919-772-18",
"PackageDescription": "50 VIAL, GLASS in 1 KIT (71919-772-18) > 1 KIT in 1 VIAL, GLASS (71919-772-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-138-01) * 750 PELLET in 1 VIAL, GLASS (68428-080-01) * 750 PELLET in 1 VIAL, GLASS (68428-117-01) * 750 PELLET in 1 VIAL, GLASS (68428-097-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 750 PELLET in 1 VIAL, GLASS (68428-085-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-092-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-133-01) * 750 PELLET in 1 VIAL, GLASS (68428-124-01) * 750 PELLET in 1 VIAL, GLASS (68428-115-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 750 PELLET in 1 VIAL, GLASS (68428-095-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-147-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (68428-078-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-111-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-123-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 750 PELLET in 1 VIAL, GLASS (68428-142-01) * 750 PELLET in 1 VIAL, GLASS (68428-102-01) * 750 PELLET in 1 VIAL, GLASS (68428-122-01) * 750 PELLET in 1 VIAL, GLASS (68428-118-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 750 PELLET in 1 VIAL, GLASS (68428-146-01) * 750 PELLET in 1 VIAL, GLASS (68428-144-01) * 750 PELLET in 1 VIAL, GLASS (68428-125-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-156-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-082-01) * 750 PELLET in 1 VIAL, GLASS (68428-127-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-105-01) ",
"NDC11Code": "71919-0772-18",
"ProductNDC": "71919-772",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "30c And 200c Homeopathic Remedy Kit",
"NonProprietaryName": "50 Remedy Kit",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20220610",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220610",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. ACONITUM NAPELLUS Fear ALLIUM CEPA Head cold ANTIMONIUM TART Loose cough APIS MELLIFICA Stings ARGENTUM NITRICUM Impulsiveness ARNICA MONTANA Trauma ARSENICUM ALBUM Food poisoning BELLADONNA Fever BRYONIA ALBA Worse motion CALCAREA CARBONICA Overwork CALCAREA PHOSPHORICA Stiffness CALENDULA OFFICINALIS Wounds CANTHARIS Urinary tract CARBO VEGETABILIS Exhaustion CAULOPHYLLUM THAL Cramps CAUSTICUM Hoarseness CHAMOMILLA Irritability CINCHONA OFFICINALIS Debility COCCULUS INDICUS Motion sickness COFFEA CRUDA Sleeplessness COLOCYNTHIS Colic-like pain EUPHRASIA OFFICINALIS Eye irritation FERRUM PHOSPHORICUM Low fever GELSEMIUM SEMPERVIRENS Lethargy GLONOINUM Throbbing HEPAR SULPHURIS CALCAREUM Croupiness HYPERICUM PERFORATUM Shooting pain IGNATIA AMARA Sadness IPECACUANHA Nausea KALI BICHROMICUM Sinuses LACHESIS MUTUS Sore throat LEDUM PALUSTRE Black eyes LYCOPODIUM Digestion MAGNESIA PHOSPHORICA Cramps MERCURIUS VIVUS Sore throat NATRUM MURIATICUM Sneezing NUX VOMICA Vomiting PHOSPHORUS Hoarseness PHYTOLACCA Breast pain PULSATILLA Weeping PYROGENIUM Abscesses RHUS TOXICODENDRON Better motion RUTA GRAVEOLENS Bruised feeling SEPIA Indifference SILICEA Formation of pus SPONGIA TOSTA Wheezing STAPHYSAGRIA Anger SULFUR Skin problems SYMPHYTUM OFFICINALE Prickling pain THUJA OCCIDENTALIS Warts."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>27241-092-50</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (27241-092-50) </PackageDescription>
<NDC11Code>27241-0092-50</NDC11Code>
<ProductNDC>27241-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207797</ApplicationNumber>
<LabelerName>Ajanta Pharma Limited</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>4.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild to moderate dementia of the Alzheimer’s type (1.1), 2 Mild to moderate dementia associated with Parkinson’s disease (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate, USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)- tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine tartrate capsules, USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides. Imprinting ink contains: shellac, propylene glycol, black iron oxide and potassium hydroxide. Rivastigmine tartrate capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>27241-092-06</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (27241-092-06) </PackageDescription>
<NDC11Code>27241-0092-06</NDC11Code>
<ProductNDC>27241-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207797</ApplicationNumber>
<LabelerName>Ajanta Pharma Limited</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>4.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild to moderate dementia of the Alzheimer’s type (1.1), 2 Mild to moderate dementia associated with Parkinson’s disease (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate, USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)- tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine tartrate capsules, USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides. Imprinting ink contains: shellac, propylene glycol, black iron oxide and potassium hydroxide. Rivastigmine tartrate capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>27241-001-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (27241-001-50) </PackageDescription>
<NDC11Code>27241-0001-50</NDC11Code>
<ProductNDC>27241-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201003</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone tablets are an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red.</Description>
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<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
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<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Risperidone tablets are an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
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<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Risperidone tablets are an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red.</Description>
</NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20140328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201003</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Risperidone tablets are an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red.</Description>
</NDC>
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<PackageDescription>500 TABLET in 1 BOTTLE (27241-005-50) </PackageDescription>
<NDC11Code>27241-0005-50</NDC11Code>
<ProductNDC>27241-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201003</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone tablets are an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red.</Description>
</NDC>
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<PackageDescription>500 TABLET in 1 BOTTLE (27241-006-50) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201003</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone tablets are an atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2) , 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red.</Description>
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<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (27241-007-50) </PackageDescription>
<NDC11Code>27241-0007-50</NDC11Code>
<ProductNDC>27241-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201293</ApplicationNumber>
<LabelerName>Ajanta Pharma Limited</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Levetiracetam is indicated for adjunctive therapy in the treatment of: : 1 Partial onset seizures in patients one month of age and older with epilepsy (1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) .</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (yellow), 500 mg (orange), 750 mg (blue), and 1000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP, is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam tablets contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, povidone K30, colloidal silicon dioxide, talc, magnesium stearate, titanium dioxide, polyethylene glycol 3350, lecithin, polyvinyl alcohol, and additional agents listed below: 250 mg tablets: yellow iron oxide 500 mg tablets: iron oxide red, FD&C Yellow #6 aluminum lake 750 mg tablets: FD&C Blue #2 aluminum lake Meets USP Dissolution Method: Test 3.</Description>
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<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (27241-008-50) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201293</ApplicationNumber>
<LabelerName>Ajanta Pharma Limited</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Levetiracetam is indicated for adjunctive therapy in the treatment of: : 1 Partial onset seizures in patients one month of age and older with epilepsy (1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) .</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (yellow), 500 mg (orange), 750 mg (blue), and 1000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP, is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam tablets contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, povidone K30, colloidal silicon dioxide, talc, magnesium stearate, titanium dioxide, polyethylene glycol 3350, lecithin, polyvinyl alcohol, and additional agents listed below: 250 mg tablets: yellow iron oxide 500 mg tablets: iron oxide red, FD&C Yellow #6 aluminum lake 750 mg tablets: FD&C Blue #2 aluminum lake Meets USP Dissolution Method: Test 3.</Description>
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<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (27241-009-50) </PackageDescription>
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<ProductNDC>27241-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20110614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201293</ApplicationNumber>
<LabelerName>Ajanta Pharma Limited</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Levetiracetam is indicated for adjunctive therapy in the treatment of: : 1 Partial onset seizures in patients one month of age and older with epilepsy (1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) .</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (yellow), 500 mg (orange), 750 mg (blue), and 1000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP, is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam tablets contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, povidone K30, colloidal silicon dioxide, talc, magnesium stearate, titanium dioxide, polyethylene glycol 3350, lecithin, polyvinyl alcohol, and additional agents listed below: 250 mg tablets: yellow iron oxide 500 mg tablets: iron oxide red, FD&C Yellow #6 aluminum lake 750 mg tablets: FD&C Blue #2 aluminum lake Meets USP Dissolution Method: Test 3.</Description>
</NDC>
<NDC>
<NDCCode>27241-020-50</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-020-50) </PackageDescription>
<NDC11Code>27241-0020-50</NDC11Code>
<ProductNDC>27241-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203957</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1) , 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2) , 3 Maintenance of healed duodenal ulcers in adults. (1.3) , 4 Treatment of active benign gastric ulcer in adults. (1.4) , 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8) , 9 Maintenance of healing of EE in adults. (1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10) .</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, magnesium carbonate, talc, polyethylene glycol, hydroxypropyl cellulose, colloidal silicon dioxide, hypromellose, ferric oxide red, ferric oxide black, ferric oxide yellow, sodium bicarbonate, sodium lauryl sulfate. The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Lansoprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>27241-090-50</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (27241-090-50) </PackageDescription>
<NDC11Code>27241-0090-50</NDC11Code>
<ProductNDC>27241-090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207797</ApplicationNumber>
<LabelerName>Ajanta Pharma Limited</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild to moderate dementia of the Alzheimer’s type (1.1), 2 Mild to moderate dementia associated with Parkinson’s disease (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate, USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)- tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine tartrate capsules, USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides. Imprinting ink contains: shellac, propylene glycol, black iron oxide and potassium hydroxide. Rivastigmine tartrate capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>27241-091-50</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (27241-091-50) </PackageDescription>
<NDC11Code>27241-0091-50</NDC11Code>
<ProductNDC>27241-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207797</ApplicationNumber>
<LabelerName>Ajanta Pharma Limited</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild to moderate dementia of the Alzheimer’s type (1.1), 2 Mild to moderate dementia associated with Parkinson’s disease (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate, USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)- tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine tartrate capsules, USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides. Imprinting ink contains: shellac, propylene glycol, black iron oxide and potassium hydroxide. Rivastigmine tartrate capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>27241-093-50</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (27241-093-50) </PackageDescription>
<NDC11Code>27241-0093-50</NDC11Code>
<ProductNDC>27241-093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207797</ApplicationNumber>
<LabelerName>Ajanta Pharma Limited</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild to moderate dementia of the Alzheimer’s type (1.1), 2 Mild to moderate dementia associated with Parkinson’s disease (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate, USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)- tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine tartrate capsules, USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides. Imprinting ink contains: shellac, propylene glycol, black iron oxide and potassium hydroxide. Rivastigmine tartrate capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>27241-109-50</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (27241-109-50) </PackageDescription>
<NDC11Code>27241-0109-50</NDC11Code>
<ProductNDC>27241-109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180927</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209859</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranitidine capsules are indicated in: 1 Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year., 3 The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg two times a day., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
<Description>Ranitidine hydrochloride (HCl) USP, is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine,hydrochloride. It has the following structure. The empirical formula is C13H22N4O3S HCl, representing a molecular weight of 350.8. Ranitidine HCl is a white to pale yellow crystalline, practically odorless powder. Very soluble in water, sparingly soluble in alcohol. Each capsule, for oral administration contains 168 mg or 336 mg of ranitidine hydrochloride equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: Silicon dioxide, corn starch, magnesium stearate, and sodium starch glycolate Type A corn. Each hard-gelatin capsule contains gelatin, titanium dioxide, FD&C Blue no. 1, FD&C Red no. 40, and FD&C Yellow no. 6. Imprinting ink contains: shellac, propylene glycol, ferrosoferric oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>27241-140-42</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (27241-140-42) </PackageDescription>
<NDC11Code>27241-0140-42</NDC11Code>
<ProductNDC>27241-140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211012</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate, USP and other antibacterial drugs, doxycycline hyclate capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment:. Doxycycline, USP is indicated for the treatment of the following infections:. Doxycycline, USP is also indicated for the treatment of infections caused by the following gram-negative microorganisms. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline, USP is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: : 1 Escherichia coli., 2 Enterobacter aerogenes. , 3 Shigella species., 4 Acinetobacter species., 5 Respiratory tract infections caused by Haemophilus influenzae., 6 Respiratory tract and urinary tract infections caused by Klebsiella species. .</IndicationAndUsage>
<Description>Doxycycline hyclate, USP is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules, USP for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate, USP is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: hard gelatin capsules (contains FD&C Blue 1, gelatin and titanium dioxide); magnesium stearate; microcrystalline cellulose; sodium lauryl sulfate. The black imprinting ink contains black iron oxide, propylene glycol, shellac, and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>27241-141-42</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (27241-141-42) </PackageDescription>
<NDC11Code>27241-0141-42</NDC11Code>
<ProductNDC>27241-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211012</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate, USP and other antibacterial drugs, doxycycline hyclate capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment:. Doxycycline, USP is indicated for the treatment of the following infections:. Doxycycline, USP is also indicated for the treatment of infections caused by the following gram-negative microorganisms. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline, USP is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: : 1 Escherichia coli., 2 Enterobacter aerogenes. , 3 Shigella species., 4 Acinetobacter species., 5 Respiratory tract infections caused by Haemophilus influenzae., 6 Respiratory tract and urinary tract infections caused by Klebsiella species. .</IndicationAndUsage>
<Description>Doxycycline hyclate, USP is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules, USP for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate, USP is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: hard gelatin capsules (contains FD&C Blue 1, gelatin and titanium dioxide); magnesium stearate; microcrystalline cellulose; sodium lauryl sulfate. The black imprinting ink contains black iron oxide, propylene glycol, shellac, and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>27241-249-49</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (27241-249-49) </PackageDescription>
<NDC11Code>27241-0249-49</NDC11Code>
<ProductNDC>27241-249</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220425</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217529</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine for oral suspension is indicated in adults for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy., 5 treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias)., 6 reduction of the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>The active ingredient in famotidine for oral suspension USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45 Its structural formula is. Each 5 mL of famotidine for oral suspension USP when prepared as directed contains 40 mg of famotidine USP and the following inactive ingredients: citric acid monohydrate, flavors (cherry, banana and peppermint), powdered cellulose, sucrose, sucralose, xanthan gum. Added as preservatives are methylparaben sodium, propylparaben sodium, and sodium benzoate. Famotidine USP is a white to pale yellow crystalline powder that is freely soluble in dimethyl formamide, glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>11489-092-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11489-092-01) > 50 g in 1 JAR</PackageDescription>
<NDC11Code>11489-0092-01</NDC11Code>
<ProductNDC>11489-092</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No7 Protect And Perfect Intense Day Cream Spf 15</ProprietaryName>
<NonProprietaryName>Avobenzone,octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150707</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BCM Ltd</LabelerName>
<SubstanceName>AVOBENZONE; OCTOCRYLENE; OCTISALATE</SubstanceName>
<StrengthNumber>1.5; 2; 1</StrengthNumber>
<StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>41250-092-50</NDCCode>
<PackageDescription>50 LOZENGE in 1 BAG (41250-092-50) </PackageDescription>
<NDC11Code>41250-0092-50</NDC11Code>
<ProductNDC>41250-092</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Herbal Cough Drop</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160512</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Meijer Distribution Inc.</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>4.8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46672-092-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (46672-092-50) </PackageDescription>
<NDC11Code>46672-0092-50</NDC11Code>
<ProductNDC>46672-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040846</ApplicationNumber>
<LabelerName>Mikart, LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>2.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47682-092-33</NDCCode>
<PackageDescription>50 PACKET in 1 BOX (47682-092-33) > 2 TABLET, CHEWABLE in 1 PACKET</PackageDescription>
<NDC11Code>47682-0092-33</NDC11Code>
<ProductNDC>47682-092</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi First Plus Antacid</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081230</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>420</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. relieves: 1 acid indigestion, 2 sour stomach, 3 heartburn, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53747-092-00</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (53747-092-00) / 50 kg in 1 BAG</PackageDescription>
<NDC11Code>53747-0092-00</NDC11Code>
<ProductNDC>53747-092</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ticagrelor</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190326</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Unichem Laboratories Limited, India</LabelerName>
<SubstanceName>TICAGRELOR</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-12-12</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>26-MAR-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>54575-092-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (54575-092-50)</PackageDescription>
<NDC11Code>54575-0092-50</NDC11Code>
<ProductNDC>54575-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Meadow Fescue Grass Pollen</ProprietaryName>
<NonProprietaryName>Festuca Elatior Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19970529</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101381</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>FESTUCA PRATENSIS POLLEN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Standardized grass pollen extracts are used for the diagnosis and treatment of allergic disease to grass pollen. The standardized (Bioequivalent Allergy Unit) extract in these vials is designed primarily for the physician equipped to prepare dilutions and mixtures as required. STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/ml ARE NOT INTERCHANGEABLE WITH GRASS POLLEN EXTRACTS LABELED IN AU/ml OR WITH NON-STANDARDIZED (WEIGHT/VOLUME) GRASS POLLEN EXTRACTS. Patients being switched from other types of extracts to Allergy Laboratories should have their dose adjusted. Diagnosis of allergic disease to these grasses is made through a combined medical history sufficiently complete to identify allergic symptoms to grass pollen and identification of grass allergy by diagnostic skin testing. It is recommended that diagnostic skin testing (scratch or puncture) be performed with 10,000 BAU/ml grass pollen extracts before testing with 100,000 BAU/ml grass pollen extracts. 10,000 BAU/mL and 100,000 BAU/ml grass pollen extracts for immunotherapy are available for previously treated patients to facilitate dose selection for safe switching from non-standardized to standardized extracts. Patients being treated with grass pollen extracts for the first time can be initially immunized with dilutions prepared from the 10,000 BAU/ml extract (see Dosage and Administration). 100,000 BAU/ml grass pollen extract can be administered if the patient tolerates the 10,000 BAU/ml extract. Grass pollen immunotherapy is intended for patients whose grass allergic symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5).</IndicationAndUsage>
<Description>Standardized grass pollen extracts labeled in BAU/ml are not interchangeable with grass pollen extracts labeled in AU/ml or with non-standardized grass pollen extracts. The recommended route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Do not inject intravenously. The extract is sterile and contains 50% (v/v) glycerin as a preservative. Standardized grass pollen extracts are available in both 10,000 BAU/ml and 100,000 BAU/ml potencies, except for Bermuda which is only available in 10,000 BAU/ml. The source material of the standardized grass extracts are the grass pollens. The 100,000 BAU/ml grass pollen extracts are prepared by extracting pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 100,000 BAU/ml. The 10,000 BAU/ml grass pollen extracts are prepared by dilution of the 100,000 BAU/ml grass pollen extracts. The 10,000 BAU/ml Bermuda grass pollen extract is prepared by extracting Bermuda grass pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 10,000 BAU/ml. The potency (in Bioequivalent Allergy Units per ml or BAU/ml) of standardized grass pollen extracts is determined by an in-vitro ELISA Competition assay (1) against CBER reference extracts and CBER reference serum pools distributed by the Center for Biologics Evaluation and Research, U S Food and Drug Administration. Potency based on Bioequivalent Allergy Units (BAU/ml) is printed on the label. FDA reference grass pollen extracts were assigned potency designations based on quantitative skin testing (2). The FDA reference extracts which can be diluted 1:500,000 fold intradermally to produce a sum of erythema diameter response of 50mm in highly puncture reactive subjects have been assigned 10,000 BAU/ml. References which can be diluted 1:5,000,000 fold intraderrnally to produce a sum of erythema diameter response of 50mm have been assigned 100,000 BAU/ml.</Description>
</NDC>
<NDC>
<NDCCode>57344-092-03</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (57344-092-03) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>57344-0092-03</NDC11Code>
<ProductNDC>57344-092</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>AAA Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69584-092-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (69584-092-50) </PackageDescription>
<NDC11Code>69584-0092-50</NDC11Code>
<ProductNDC>69584-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075388</ApplicationNumber>
<LabelerName>Oxford Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP 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, USP is supplied as tablets for oral administration containing 5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, and 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 and 30-mg tablets are provided in the adjustable dosage tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15-mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30-mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride, USP tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A).</Description>
</NDC>
<NDC>
<NDCCode>69766-092-01</NDCCode>
<PackageDescription>50 kg in 1 DRUM (69766-092-01) </PackageDescription>
<NDC11Code>69766-0092-01</NDC11Code>
<ProductNDC>69766-092</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20201211</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>MSN Life Sciences Private Limited</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-14</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-DEC-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71919-092-09</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (71919-092-09) </PackageDescription>
<NDC11Code>71919-0092-09</NDC11Code>
<ProductNDC>71919-092</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Asarum Europaeum</ProprietaryName>
<NonProprietaryName>Asarum Europaeum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091120</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ASARUM EUROPAEUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-772-18</NDCCode>
<PackageDescription>50 VIAL, GLASS in 1 KIT (71919-772-18) > 1 KIT in 1 VIAL, GLASS (71919-772-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-138-01) * 750 PELLET in 1 VIAL, GLASS (68428-080-01) * 750 PELLET in 1 VIAL, GLASS (68428-117-01) * 750 PELLET in 1 VIAL, GLASS (68428-097-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 750 PELLET in 1 VIAL, GLASS (68428-085-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-092-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-133-01) * 750 PELLET in 1 VIAL, GLASS (68428-124-01) * 750 PELLET in 1 VIAL, GLASS (68428-115-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 750 PELLET in 1 VIAL, GLASS (68428-095-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-147-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (68428-078-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-111-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-123-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 750 PELLET in 1 VIAL, GLASS (68428-142-01) * 750 PELLET in 1 VIAL, GLASS (68428-102-01) * 750 PELLET in 1 VIAL, GLASS (68428-122-01) * 750 PELLET in 1 VIAL, GLASS (68428-118-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 750 PELLET in 1 VIAL, GLASS (68428-146-01) * 750 PELLET in 1 VIAL, GLASS (68428-144-01) * 750 PELLET in 1 VIAL, GLASS (68428-125-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-156-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-082-01) * 750 PELLET in 1 VIAL, GLASS (68428-127-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-105-01) </PackageDescription>
<NDC11Code>71919-0772-18</NDC11Code>
<ProductNDC>71919-772</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>30c And 200c Homeopathic Remedy Kit</ProprietaryName>
<NonProprietaryName>50 Remedy Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220610</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. ACONITUM NAPELLUS Fear ALLIUM CEPA Head cold ANTIMONIUM TART Loose cough APIS MELLIFICA Stings ARGENTUM NITRICUM Impulsiveness ARNICA MONTANA Trauma ARSENICUM ALBUM Food poisoning BELLADONNA Fever BRYONIA ALBA Worse motion CALCAREA CARBONICA Overwork CALCAREA PHOSPHORICA Stiffness CALENDULA OFFICINALIS Wounds CANTHARIS Urinary tract CARBO VEGETABILIS Exhaustion CAULOPHYLLUM THAL Cramps CAUSTICUM Hoarseness CHAMOMILLA Irritability CINCHONA OFFICINALIS Debility COCCULUS INDICUS Motion sickness COFFEA CRUDA Sleeplessness COLOCYNTHIS Colic-like pain EUPHRASIA OFFICINALIS Eye irritation FERRUM PHOSPHORICUM Low fever GELSEMIUM SEMPERVIRENS Lethargy GLONOINUM Throbbing HEPAR SULPHURIS CALCAREUM Croupiness HYPERICUM PERFORATUM Shooting pain IGNATIA AMARA Sadness IPECACUANHA Nausea KALI BICHROMICUM Sinuses LACHESIS MUTUS Sore throat LEDUM PALUSTRE Black eyes LYCOPODIUM Digestion MAGNESIA PHOSPHORICA Cramps MERCURIUS VIVUS Sore throat NATRUM MURIATICUM Sneezing NUX VOMICA Vomiting PHOSPHORUS Hoarseness PHYTOLACCA Breast pain PULSATILLA Weeping PYROGENIUM Abscesses RHUS TOXICODENDRON Better motion RUTA GRAVEOLENS Bruised feeling SEPIA Indifference SILICEA Formation of pus SPONGIA TOSTA Wheezing STAPHYSAGRIA Anger SULFUR Skin problems SYMPHYTUM OFFICINALE Prickling pain THUJA OCCIDENTALIS Warts.</IndicationAndUsage>
</NDC>
</NDCList>