{
"NDC": [
{
"NDCCode": "62756-148-86",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (62756-148-86) ",
"NDC11Code": "62756-0148-86",
"ProductNDC": "62756-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077131",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100701",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to- moderate dementia associated with Parkinson’s disease (PD) (1.2).",
"Description": "Rivastigmine tartrate 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 a molecular formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.43 g/mol (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. Rivastigmine tartrate capsules 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 magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide, D & C Red # 28 (1.5 mg), D & C Yellow # 10 (1.5 mg), FD & C Yellow # 6 (1.5 mg, 3 mg, 6 mg), FD & C Red # 40 (6 mg), red iron oxide (4.5 mg, 6 mg) and yellow iron oxide (4.5 mg, 6 mg). The imprinting ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide."
},
{
"NDCCode": "62756-148-13",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (62756-148-13) ",
"NDC11Code": "62756-0148-13",
"ProductNDC": "62756-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077131",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100701",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to- moderate dementia associated with Parkinson’s disease (PD) (1.2).",
"Description": "Rivastigmine tartrate 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 a molecular formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.43 g/mol (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. Rivastigmine tartrate capsules 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 magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide, D & C Red # 28 (1.5 mg), D & C Yellow # 10 (1.5 mg), FD & C Yellow # 6 (1.5 mg, 3 mg, 6 mg), FD & C Red # 40 (6 mg), red iron oxide (4.5 mg, 6 mg) and yellow iron oxide (4.5 mg, 6 mg). The imprinting ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide."
},
{
"NDCCode": "62756-148-61",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (62756-148-61) > 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "62756-0148-61",
"ProductNDC": "62756-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077131",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100701",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to- moderate dementia associated with Parkinson’s disease (PD) (1.2).",
"Description": "Rivastigmine tartrate 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 a molecular formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.43 g/mol (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. Rivastigmine tartrate capsules 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 magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide, D & C Red # 28 (1.5 mg), D & C Yellow # 10 (1.5 mg), FD & C Yellow # 6 (1.5 mg, 3 mg, 6 mg), FD & C Red # 40 (6 mg), red iron oxide (4.5 mg, 6 mg) and yellow iron oxide (4.5 mg, 6 mg). The imprinting ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide."
},
{
"NDCCode": "62756-145-86",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (62756-145-86) ",
"NDC11Code": "62756-0145-86",
"ProductNDC": "62756-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077131",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100701",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to- moderate dementia associated with Parkinson’s disease (PD) (1.2).",
"Description": "Rivastigmine tartrate 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 a molecular formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.43 g/mol (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. Rivastigmine tartrate capsules 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 magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide, D & C Red # 28 (1.5 mg), D & C Yellow # 10 (1.5 mg), FD & C Yellow # 6 (1.5 mg, 3 mg, 6 mg), FD & C Red # 40 (6 mg), red iron oxide (4.5 mg, 6 mg) and yellow iron oxide (4.5 mg, 6 mg). The imprinting ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide."
},
{
"NDCCode": "62756-146-86",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (62756-146-86) ",
"NDC11Code": "62756-0146-86",
"ProductNDC": "62756-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077131",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100701",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to- moderate dementia associated with Parkinson’s disease (PD) (1.2).",
"Description": "Rivastigmine tartrate 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 a molecular formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.43 g/mol (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. Rivastigmine tartrate capsules 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 magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide, D & C Red # 28 (1.5 mg), D & C Yellow # 10 (1.5 mg), FD & C Yellow # 6 (1.5 mg, 3 mg, 6 mg), FD & C Red # 40 (6 mg), red iron oxide (4.5 mg, 6 mg) and yellow iron oxide (4.5 mg, 6 mg). The imprinting ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide."
},
{
"NDCCode": "62756-147-86",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (62756-147-86) ",
"NDC11Code": "62756-0147-86",
"ProductNDC": "62756-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077131",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100701",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to- moderate dementia associated with Parkinson’s disease (PD) (1.2).",
"Description": "Rivastigmine tartrate 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 a molecular formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.43 g/mol (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. Rivastigmine tartrate capsules 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 magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide, D & C Red # 28 (1.5 mg), D & C Yellow # 10 (1.5 mg), FD & C Yellow # 6 (1.5 mg, 3 mg, 6 mg), FD & C Red # 40 (6 mg), red iron oxide (4.5 mg, 6 mg) and yellow iron oxide (4.5 mg, 6 mg). The imprinting ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide."
},
{
"NDCCode": "62756-238-86",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (62756-238-86) ",
"NDC11Code": "62756-0238-86",
"ProductNDC": "62756-238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Capecitabine",
"NonProprietaryName": "Capecitabine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204668",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CAPECITABINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "Capecitabine is a nucleoside metabolic inhibitor indicated for. Colorectal Cancer: 1 adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1), 2 perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (1.1), 3 treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1).",
"Description": "Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5’-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C15H22FN3O6 and a molecular weight of 359.35. Capecitabine has the following structural formula. Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20ºC. Capecitabine tablets, USP are supplied as oval, biconvex, film-coated tablets for oral administration. Each light peach colored tablets debossed with ‘150’ on one side and plain on other side contains 150 mg of capecitabine USP and each peach colored tablet debossed with ‘500’ on one side and plain on other side contains 500 mg of capecitabine USP. The inactive ingredients in capecitabine tablets include: microcrystalline cellulose, croscarmellose sodium, hypromellose, anhydrous lactose, talc and magnesium stearate. The peach or light peach film coating contains hypromellose, titanium dioxide, lactose monohydrate, polyethylene glycol, red iron oxide and yellow iron oxide."
},
{
"NDCCode": "62756-429-86",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-429-86) ",
"NDC11Code": "62756-0429-86",
"ProductNDC": "62756-429",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dalfampridine",
"NonProprietaryName": "Dalfampridine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208292",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DALFAMPRIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190522",
"SamplePackage": "N",
"IndicationAndUsage": "Dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14)].",
"Description": "Dalfampridine, USP is a potassium channel blocker, available in 10 mg tablet strength. Each tablet contains 10 mg dalfampridine, formulated as an extended-release tablet for twice-daily oral administration. Dalfampridine is also known by its chemical name, 4-aminopyridine, with the following structure. Dalfampridine extended-release tablets are available in 10 mg strength and are white to off-white, round, biconvex, beveled edged, film-coated tablets imprinted with “429” in black ink on one side and plain on the other side, containing 10 mg of dalfampridine. Inactive ingredients consist of hypromellose, povidone, microcrystalline cellulose and magnesium stearate. The film-coating contains hypromellose, talc, ethyl cellulose, triacetin and titanium dioxide. The imprinting ink contains shellac glaze, iron oxide black, n-butyl alcohol, propylene glycol and ammonium hydroxide. Dalfampridine, USP is a white to off-white crystalline powder with a molecular weight of 94.1, CAS 504-24-5, and a molecular formula of C5H6N2. At ambient conditions, dalfampridine is soluble in water, methanol, acetone, tetrahydrofuran, isopropanol, acetonitrile, N, N-dimethylformamide, dimethylsulfoxide, and ethanol."
},
{
"NDCCode": "62756-538-86",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (62756-538-86) ",
"NDC11Code": "62756-0538-86",
"ProductNDC": "62756-538",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Riluzole",
"NonProprietaryName": "Riluzole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091417",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "RILUZOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzothiazole [EPC], Benzothiazoles [CS]",
"Status": "Active",
"LastUpdate": "2020-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130618",
"SamplePackage": "N",
"IndicationAndUsage": "Riluzole tablets, USP are indicated for the treatment of amyotrophic lateral sclerosis (ALS).",
"Description": "Riluzole is a member of the benzothiazole class. The chemical designation for riluzole is 2-amino-6-(trifluoromethoxy) benzothiazole. Its molecular formula is C8H5F3N2OS, and its molecular weight is 234.2. The chemical structure is. Riluzole is a white to slightly yellow powder that is very soluble in dimethylformamide, dimethylsulfoxide, and methanol; freely soluble in dichloromethane; sparingly soluble in 0.1 N HCl; and very slightly soluble in water and in 0.1 N NaOH. Each film-coated tablet for oral use contains 50 mg of riluzole, USP and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, talc and titanium dioxide."
},
{
"NDCCode": "62756-568-86",
"PackageDescription": "60 TABLET, FOR SUSPENSION in 1 BOTTLE (62756-568-86) ",
"NDC11Code": "62756-0568-86",
"ProductNDC": "62756-568",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209782",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191202",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4 g/mol. Inactive Ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate."
},
{
"NDCCode": "62756-569-86",
"PackageDescription": "60 TABLET, FOR SUSPENSION in 1 BOTTLE (62756-569-86) ",
"NDC11Code": "62756-0569-86",
"ProductNDC": "62756-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209782",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191202",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4 g/mol. Inactive Ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate."
},
{
"NDCCode": "62756-570-86",
"PackageDescription": "60 TABLET, FOR SUSPENSION in 1 BOTTLE (62756-570-86) ",
"NDC11Code": "62756-0570-86",
"ProductNDC": "62756-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209782",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191202",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4 g/mol. Inactive Ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate."
},
{
"NDCCode": "62756-707-86",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (62756-707-86) ",
"NDC11Code": "62756-0707-86",
"ProductNDC": "62756-707",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2018-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090327",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is an antiepileptic (AED) agent indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2) .",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "62756-710-86",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (62756-710-86) ",
"NDC11Code": "62756-0710-86",
"ProductNDC": "62756-710",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2018-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090327",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is an antiepileptic (AED) agent indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2) .",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "62756-711-86",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (62756-711-86) ",
"NDC11Code": "62756-0711-86",
"ProductNDC": "62756-711",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2018-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090327",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is an antiepileptic (AED) agent indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2) .",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "62756-712-86",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (62756-712-86) ",
"NDC11Code": "62756-0712-86",
"ProductNDC": "62756-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2018-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090327",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is an antiepileptic (AED) agent indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2) .",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "50242-138-86",
"PackageDescription": "1 SYRINGE, GLASS in 1 BOX (50242-138-86) / .9 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50242-0138-86",
"ProductNDC": "50242-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Actemra",
"NonProprietaryName": "Tocilizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20131021",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125472",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "TOCILIZUMAB",
"StrengthNumber": "162",
"StrengthUnit": "mg/.9mL",
"Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131021",
"SamplePackage": "Y",
"IndicationAndUsage": "ACTEMRA® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of. Rheumatoid Arthritis (RA) (1.1): 1 Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).",
"Description": "Tocilizumab is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H2L2 polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. ACTEMRA has a molecular weight of approximately 148 kDa. The antibody is produced in mammalian (Chinese hamster ovary) cells."
},
{
"NDCCode": "50242-143-86",
"PackageDescription": "1 SYRINGE, GLASS in 1 BOX (50242-143-86) / .9 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50242-0143-86",
"ProductNDC": "50242-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Actemra Actpen",
"NonProprietaryName": "Tocilizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20181119",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125472",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "TOCILIZUMAB",
"StrengthNumber": "162",
"StrengthUnit": "mg/.9mL",
"Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181119",
"SamplePackage": "Y",
"IndicationAndUsage": "ACTEMRA® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of. Rheumatoid Arthritis (RA) (1.1): 1 Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).",
"Description": "Tocilizumab is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H2L2 polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. ACTEMRA has a molecular weight of approximately 148 kDa. The antibody is produced in mammalian (Chinese hamster ovary) cells."
},
{
"NDCCode": "50242-245-86",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50242-245-86) / 15 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50242-0245-86",
"ProductNDC": "50242-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phesgo",
"NonProprietaryName": "Pertuzumab, Trastuzumab, And Hyaluronidase-zzxf",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200629",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761170",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "PERTUZUMAB; TRASTUZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)",
"StrengthNumber": "1200; 600; 30000",
"StrengthUnit": "mg/15mL; mg/15mL; U/15mL",
"Pharm_Classes": "Endoglycosidase [EPC], Glycoside Hydrolases [CS], HER2/Neu/cerbB2 Antagonists [MoA], HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC], HER2/neu Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210503",
"SamplePackage": "Y",
"IndicationAndUsage": "PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for: 1 Use in combination with chemotherapy as:neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. (1.1)adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (1.1), 2 Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. (1.2).",
"Description": "PHESGO is a combination of pertuzumab, trastuzumab, and hyaluronidase. Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Pertuzumab has an approximate molecular weight of 148 kDa. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Trastuzumab has a molecular weight of approximately 148 kDa. Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by mammalian (Chinese Hamster Ovary) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa. PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection is a sterile, preservative-free, clear to opalescent, and colorless to slightly brownish solution supplied in single-dose vials for subcutaneous administration. PHESGO injection is supplied as two different configurations: 1 PHESGO is supplied in a 15 mL single-dose vial containing 1,200 mg of pertuzumab, 600 mg of trastuzumab, and 30,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (6.75 mg), L-histidine hydrochloric monohydrate (53.7 mg), L-methionine (22.4 mg), polysorbate 20 (6 mg), and sucrose (685 mg) with a pH of 5.5., 2 PHESGO is supplied in a 10 mL single-dose vial containing 600 mg of pertuzumab, 600 mg of trastuzumab, and 20,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (4.4 mg), L-histidine hydrochloric monohydrate (36.1 mg), L-methionine (14.9 mg), polysorbate 20 (4 mg), and sucrose (342 mg) with a pH of 5.5."
},
{
"NDCCode": "50242-260-86",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50242-260-86) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50242-0260-86",
"ProductNDC": "50242-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phesgo",
"NonProprietaryName": "Pertuzumab, Trastuzumab, And Hyaluronidase-zzxf",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200629",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761170",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "PERTUZUMAB; TRASTUZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)",
"StrengthNumber": "600; 600; 20000",
"StrengthUnit": "mg/10mL; mg/10mL; U/10mL",
"Pharm_Classes": "Endoglycosidase [EPC], Glycoside Hydrolases [CS], HER2/Neu/cerbB2 Antagonists [MoA], HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC], HER2/neu Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210503",
"SamplePackage": "Y",
"IndicationAndUsage": "PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for: 1 Use in combination with chemotherapy as:neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. (1.1)adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (1.1), 2 Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. (1.2).",
"Description": "PHESGO is a combination of pertuzumab, trastuzumab, and hyaluronidase. Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Pertuzumab has an approximate molecular weight of 148 kDa. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Trastuzumab has a molecular weight of approximately 148 kDa. Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by mammalian (Chinese Hamster Ovary) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa. PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection is a sterile, preservative-free, clear to opalescent, and colorless to slightly brownish solution supplied in single-dose vials for subcutaneous administration. PHESGO injection is supplied as two different configurations: 1 PHESGO is supplied in a 15 mL single-dose vial containing 1,200 mg of pertuzumab, 600 mg of trastuzumab, and 30,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (6.75 mg), L-histidine hydrochloric monohydrate (53.7 mg), L-methionine (22.4 mg), polysorbate 20 (6 mg), and sucrose (685 mg) with a pH of 5.5., 2 PHESGO is supplied in a 10 mL single-dose vial containing 600 mg of pertuzumab, 600 mg of trastuzumab, and 20,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (4.4 mg), L-histidine hydrochloric monohydrate (36.1 mg), L-methionine (14.9 mg), polysorbate 20 (4 mg), and sucrose (342 mg) with a pH of 5.5."
},
{
"NDCCode": "50474-983-86",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (50474-983-86) / 6 mL in 1 VIAL, GLASS",
"NDC11Code": "50474-0983-86",
"ProductNDC": "50474-983",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rystiggo",
"NonProprietaryName": "Rozanolixizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240614",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761286",
"LabelerName": "UCB, Inc.",
"SubstanceName": "ROZANOLIXIZUMAB",
"StrengthNumber": "140",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neonatal Fc Receptor Blocker [EPC], Neonatal Fc Receptor Blockers [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240715",
"SamplePackage": "N",
"IndicationAndUsage": "RYSTIGGO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.",
"Description": "Rozanolixizumab-noli, a neonatal Fc receptor blocker, is a recombinant, humanized IgG4P monoclonal antibody, expressed in a genetically engineered Chinese hamster ovary DG44 cell line. Rozanolixizumab-noli has an approximate molecular weight of 148 kDa."
},
{
"NDCCode": "51759-208-13",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (51759-208-13) / 30 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "51759-0208-13",
"ProductNDC": "51759-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epysqli",
"NonProprietaryName": "Eculizumab-aagh",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250407",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761340",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ECULIZUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Complement Inhibitor [EPC], Complement Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250407",
"SamplePackage": "N",
"IndicationAndUsage": "EPYSQLI is a complement inhibitor indicated for: 1 the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. (1.1), 2 the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. (1.2)Limitation of UseEPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS)., 3 the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. (1.3), 4 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.4).",
"Description": "Eculizumab-aagh, a complement inhibitor, is a recombinant humanized monoclonal IgG2/4κ antibody produced in a Chinese Hamster Ovary cell line expression system and purified by standard bioprocess technology . Eculizumab-aagh contains human constant regions from human IgG2 sequences and human IgG4 sequences and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions. Eculizumab-aagh is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa. EPYSQLI (eculizumab-aagh) injection is a sterile, preservative-free, clear to slightly opalescent and colorless solution for intravenous infusion and is supplied in a 30 mL single-dose vial. Each mL contains 10 mg of eculizumab-aagh, dibasic sodium phosphate (0.77 mg), monobasic sodium phosphate (0.55 mg), polysorbate 80 (0.22 mg) (vegetable origin), trehalose (86 mg), and Water for Injection, USP. The pH is 7."
},
{
"NDCCode": "71202-010-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (71202-010-01) / 30 mL in 1 VIAL, SINGLE-DOSE (71202-010-07) ",
"NDC11Code": "71202-0010-01",
"ProductNDC": "71202-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epysqli",
"NonProprietaryName": "Eculizumab-aagh",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250301",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761340",
"LabelerName": "Samsung Bioepis Co., Ltd.",
"SubstanceName": "ECULIZUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Complement Inhibitor [EPC], Complement Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20250301",
"SamplePackage": "N",
"IndicationAndUsage": "EPYSQLI is a complement inhibitor indicated for: 1 the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. (1.1), 2 the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. (1.2)Limitation of UseEPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS)., 3 the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. (1.3).",
"Description": "Eculizumab-aagh, a complement inhibitor, is a recombinant humanized monoclonal IgG2/4ϰ antibody produced in a Chinese Hamster Ovary cell line expression system and purified by standard bioprocess technology . Eculizumab-aagh contains human constant regions from human IgG2 sequences and human IgG4 sequences and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions. Eculizumab-aagh is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa. EPYSQLI (eculizumab-aagh) injection is a sterile, preservative-free, clear to slightly opalescent and colorless solution for intravenous infusion and is supplied in a 30 mL single-dose vial. Each mL contains 10 mg of eculizumab-aagh, dibasic sodium phosphate (0.77 mg), monobasic sodium phosphate (0.55 mg), polysorbate 80 (0.22 mg) (vegetable origin), trehalose (86 mg), and Water for Injection, USP. The pH is 7."
},
{
"NDCCode": "62756-001-11",
"PackageDescription": "25 kg in 1 DRUM (62756-001-11) ",
"NDC11Code": "62756-0001-11",
"ProductNDC": "62756-001",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tofacitinib Citrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160404",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
"SubstanceName": "TOFACITINIB CITRATE",
"StrengthNumber": "25",
"StrengthUnit": "kg/25kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-24",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "21-NOV-25"
},
{
"NDCCode": "62756-008-60",
"PackageDescription": "1 POUCH in 1 CARTON (62756-008-60) > 1 BAG in 1 POUCH > 130 mL in 1 BAG",
"NDC11Code": "62756-0008-60",
"ProductNDC": "62756-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Infugem",
"NonProprietaryName": "Gemcitabine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208313",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N"
},
{
"NDCCode": "62756-009-30",
"PackageDescription": "1 kg in 1 DRUM (62756-009-30) ",
"NDC11Code": "62756-0009-30",
"ProductNDC": "62756-009",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bendamustine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210111",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
"SubstanceName": "BENDAMUSTINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "11-JAN-21"
},
{
"NDCCode": "62756-010-14",
"PackageDescription": "1 kg in 1 DRUM (62756-010-14) ",
"NDC11Code": "62756-0010-14",
"ProductNDC": "62756-010",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Febuxostat",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210111",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
"SubstanceName": "FEBUXOSTAT",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "11-JAN-21"
},
{
"NDCCode": "62756-011-25",
"PackageDescription": "25 kg in 1 DRUM (62756-011-25)",
"NDC11Code": "62756-0011-25",
"ProductNDC": "62756-011",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Estradiol Cypionate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20091218",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "ESTRADIOL CYPIONATE",
"StrengthNumber": "25",
"StrengthUnit": "kg/25kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "62756-012-11",
"PackageDescription": "25 kg in 1 DRUM (62756-012-11)",
"NDC11Code": "62756-0012-11",
"ProductNDC": "62756-012",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Clindamycin Palmitate Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20091222",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "CLINDAMYCIN PALMITATE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "kg/25kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "62756-014-26",
"PackageDescription": "25 g in 1 BOTTLE, GLASS (62756-014-26)",
"NDC11Code": "62756-0014-26",
"ProductNDC": "62756-014",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lubiprostone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20100114",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "LUBIPROSTONE",
"StrengthNumber": "25",
"StrengthUnit": "g/25g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>62756-148-86</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (62756-148-86) </PackageDescription>
<NDC11Code>62756-0148-86</NDC11Code>
<ProductNDC>62756-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077131</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100701</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 (AD) (1.1), 2 Mild-to- moderate dementia associated with Parkinson’s disease (PD) (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate 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 a molecular formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.43 g/mol (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. Rivastigmine tartrate capsules 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 magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide, D & C Red # 28 (1.5 mg), D & C Yellow # 10 (1.5 mg), FD & C Yellow # 6 (1.5 mg, 3 mg, 6 mg), FD & C Red # 40 (6 mg), red iron oxide (4.5 mg, 6 mg) and yellow iron oxide (4.5 mg, 6 mg). The imprinting ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>62756-148-13</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (62756-148-13) </PackageDescription>
<NDC11Code>62756-0148-13</NDC11Code>
<ProductNDC>62756-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077131</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100701</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 (AD) (1.1), 2 Mild-to- moderate dementia associated with Parkinson’s disease (PD) (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate 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 a molecular formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.43 g/mol (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. Rivastigmine tartrate capsules 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 magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide, D & C Red # 28 (1.5 mg), D & C Yellow # 10 (1.5 mg), FD & C Yellow # 6 (1.5 mg, 3 mg, 6 mg), FD & C Red # 40 (6 mg), red iron oxide (4.5 mg, 6 mg) and yellow iron oxide (4.5 mg, 6 mg). The imprinting ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>62756-148-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (62756-148-61) > 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62756-0148-61</NDC11Code>
<ProductNDC>62756-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077131</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100701</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 (AD) (1.1), 2 Mild-to- moderate dementia associated with Parkinson’s disease (PD) (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate 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 a molecular formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.43 g/mol (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. Rivastigmine tartrate capsules 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 magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide, D & C Red # 28 (1.5 mg), D & C Yellow # 10 (1.5 mg), FD & C Yellow # 6 (1.5 mg, 3 mg, 6 mg), FD & C Red # 40 (6 mg), red iron oxide (4.5 mg, 6 mg) and yellow iron oxide (4.5 mg, 6 mg). The imprinting ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>62756-145-86</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (62756-145-86) </PackageDescription>
<NDC11Code>62756-0145-86</NDC11Code>
<ProductNDC>62756-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077131</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100701</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 (AD) (1.1), 2 Mild-to- moderate dementia associated with Parkinson’s disease (PD) (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate 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 a molecular formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.43 g/mol (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. Rivastigmine tartrate capsules 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 magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide, D & C Red # 28 (1.5 mg), D & C Yellow # 10 (1.5 mg), FD & C Yellow # 6 (1.5 mg, 3 mg, 6 mg), FD & C Red # 40 (6 mg), red iron oxide (4.5 mg, 6 mg) and yellow iron oxide (4.5 mg, 6 mg). The imprinting ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>62756-146-86</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (62756-146-86) </PackageDescription>
<NDC11Code>62756-0146-86</NDC11Code>
<ProductNDC>62756-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077131</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100701</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 (AD) (1.1), 2 Mild-to- moderate dementia associated with Parkinson’s disease (PD) (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate 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 a molecular formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.43 g/mol (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. Rivastigmine tartrate capsules 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 magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide, D & C Red # 28 (1.5 mg), D & C Yellow # 10 (1.5 mg), FD & C Yellow # 6 (1.5 mg, 3 mg, 6 mg), FD & C Red # 40 (6 mg), red iron oxide (4.5 mg, 6 mg) and yellow iron oxide (4.5 mg, 6 mg). The imprinting ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>62756-147-86</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (62756-147-86) </PackageDescription>
<NDC11Code>62756-0147-86</NDC11Code>
<ProductNDC>62756-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077131</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>4.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100701</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 (AD) (1.1), 2 Mild-to- moderate dementia associated with Parkinson’s disease (PD) (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate 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 a molecular formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.43 g/mol (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. Rivastigmine tartrate capsules 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 magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide, D & C Red # 28 (1.5 mg), D & C Yellow # 10 (1.5 mg), FD & C Yellow # 6 (1.5 mg, 3 mg, 6 mg), FD & C Red # 40 (6 mg), red iron oxide (4.5 mg, 6 mg) and yellow iron oxide (4.5 mg, 6 mg). The imprinting ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>62756-238-86</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (62756-238-86) </PackageDescription>
<NDC11Code>62756-0238-86</NDC11Code>
<ProductNDC>62756-238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Capecitabine</ProprietaryName>
<NonProprietaryName>Capecitabine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204668</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CAPECITABINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Capecitabine is a nucleoside metabolic inhibitor indicated for. Colorectal Cancer: 1 adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1), 2 perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (1.1), 3 treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1).</IndicationAndUsage>
<Description>Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5’-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C15H22FN3O6 and a molecular weight of 359.35. Capecitabine has the following structural formula. Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20ºC. Capecitabine tablets, USP are supplied as oval, biconvex, film-coated tablets for oral administration. Each light peach colored tablets debossed with ‘150’ on one side and plain on other side contains 150 mg of capecitabine USP and each peach colored tablet debossed with ‘500’ on one side and plain on other side contains 500 mg of capecitabine USP. The inactive ingredients in capecitabine tablets include: microcrystalline cellulose, croscarmellose sodium, hypromellose, anhydrous lactose, talc and magnesium stearate. The peach or light peach film coating contains hypromellose, titanium dioxide, lactose monohydrate, polyethylene glycol, red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>62756-429-86</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-429-86) </PackageDescription>
<NDC11Code>62756-0429-86</NDC11Code>
<ProductNDC>62756-429</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dalfampridine</ProprietaryName>
<NonProprietaryName>Dalfampridine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208292</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DALFAMPRIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dalfampridine, USP is a potassium channel blocker, available in 10 mg tablet strength. Each tablet contains 10 mg dalfampridine, formulated as an extended-release tablet for twice-daily oral administration. Dalfampridine is also known by its chemical name, 4-aminopyridine, with the following structure. Dalfampridine extended-release tablets are available in 10 mg strength and are white to off-white, round, biconvex, beveled edged, film-coated tablets imprinted with “429” in black ink on one side and plain on the other side, containing 10 mg of dalfampridine. Inactive ingredients consist of hypromellose, povidone, microcrystalline cellulose and magnesium stearate. The film-coating contains hypromellose, talc, ethyl cellulose, triacetin and titanium dioxide. The imprinting ink contains shellac glaze, iron oxide black, n-butyl alcohol, propylene glycol and ammonium hydroxide. Dalfampridine, USP is a white to off-white crystalline powder with a molecular weight of 94.1, CAS 504-24-5, and a molecular formula of C5H6N2. At ambient conditions, dalfampridine is soluble in water, methanol, acetone, tetrahydrofuran, isopropanol, acetonitrile, N, N-dimethylformamide, dimethylsulfoxide, and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>62756-538-86</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (62756-538-86) </PackageDescription>
<NDC11Code>62756-0538-86</NDC11Code>
<ProductNDC>62756-538</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Riluzole</ProprietaryName>
<NonProprietaryName>Riluzole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130618</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091417</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>RILUZOLE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzothiazole [EPC], Benzothiazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Riluzole tablets, USP are indicated for the treatment of amyotrophic lateral sclerosis (ALS).</IndicationAndUsage>
<Description>Riluzole is a member of the benzothiazole class. The chemical designation for riluzole is 2-amino-6-(trifluoromethoxy) benzothiazole. Its molecular formula is C8H5F3N2OS, and its molecular weight is 234.2. The chemical structure is. Riluzole is a white to slightly yellow powder that is very soluble in dimethylformamide, dimethylsulfoxide, and methanol; freely soluble in dichloromethane; sparingly soluble in 0.1 N HCl; and very slightly soluble in water and in 0.1 N NaOH. Each film-coated tablet for oral use contains 50 mg of riluzole, USP and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62756-568-86</NDCCode>
<PackageDescription>60 TABLET, FOR SUSPENSION in 1 BOTTLE (62756-568-86) </PackageDescription>
<NDC11Code>62756-0568-86</NDC11Code>
<ProductNDC>62756-568</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209782</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4 g/mol. Inactive Ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>62756-569-86</NDCCode>
<PackageDescription>60 TABLET, FOR SUSPENSION in 1 BOTTLE (62756-569-86) </PackageDescription>
<NDC11Code>62756-0569-86</NDC11Code>
<ProductNDC>62756-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209782</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4 g/mol. Inactive Ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>62756-570-86</NDCCode>
<PackageDescription>60 TABLET, FOR SUSPENSION in 1 BOTTLE (62756-570-86) </PackageDescription>
<NDC11Code>62756-0570-86</NDC11Code>
<ProductNDC>62756-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209782</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4 g/mol. Inactive Ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>62756-707-86</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (62756-707-86) </PackageDescription>
<NDC11Code>62756-0707-86</NDC11Code>
<ProductNDC>62756-707</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is an antiepileptic (AED) agent indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2) .</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>62756-710-86</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (62756-710-86) </PackageDescription>
<NDC11Code>62756-0710-86</NDC11Code>
<ProductNDC>62756-710</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is an antiepileptic (AED) agent indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2) .</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>62756-711-86</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (62756-711-86) </PackageDescription>
<NDC11Code>62756-0711-86</NDC11Code>
<ProductNDC>62756-711</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is an antiepileptic (AED) agent indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2) .</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>62756-712-86</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (62756-712-86) </PackageDescription>
<NDC11Code>62756-0712-86</NDC11Code>
<ProductNDC>62756-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is an antiepileptic (AED) agent indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2) .</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>50242-138-86</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 BOX (50242-138-86) / .9 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50242-0138-86</NDC11Code>
<ProductNDC>50242-138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Actemra</ProprietaryName>
<NonProprietaryName>Tocilizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20131021</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125472</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>TOCILIZUMAB</SubstanceName>
<StrengthNumber>162</StrengthNumber>
<StrengthUnit>mg/.9mL</StrengthUnit>
<Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131021</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ACTEMRA® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of. Rheumatoid Arthritis (RA) (1.1): 1 Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).</IndicationAndUsage>
<Description>Tocilizumab is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H2L2 polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. ACTEMRA has a molecular weight of approximately 148 kDa. The antibody is produced in mammalian (Chinese hamster ovary) cells.</Description>
</NDC>
<NDC>
<NDCCode>50242-143-86</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 BOX (50242-143-86) / .9 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50242-0143-86</NDC11Code>
<ProductNDC>50242-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Actemra Actpen</ProprietaryName>
<NonProprietaryName>Tocilizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20181119</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125472</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>TOCILIZUMAB</SubstanceName>
<StrengthNumber>162</StrengthNumber>
<StrengthUnit>mg/.9mL</StrengthUnit>
<Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181119</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ACTEMRA® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of. Rheumatoid Arthritis (RA) (1.1): 1 Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).</IndicationAndUsage>
<Description>Tocilizumab is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H2L2 polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. ACTEMRA has a molecular weight of approximately 148 kDa. The antibody is produced in mammalian (Chinese hamster ovary) cells.</Description>
</NDC>
<NDC>
<NDCCode>50242-245-86</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50242-245-86) / 15 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50242-0245-86</NDC11Code>
<ProductNDC>50242-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phesgo</ProprietaryName>
<NonProprietaryName>Pertuzumab, Trastuzumab, And Hyaluronidase-zzxf</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200629</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761170</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>PERTUZUMAB; TRASTUZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)</SubstanceName>
<StrengthNumber>1200; 600; 30000</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; U/15mL</StrengthUnit>
<Pharm_Classes>Endoglycosidase [EPC], Glycoside Hydrolases [CS], HER2/Neu/cerbB2 Antagonists [MoA], HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC], HER2/neu Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210503</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for: 1 Use in combination with chemotherapy as:neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. (1.1)adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (1.1), 2 Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. (1.2).</IndicationAndUsage>
<Description>PHESGO is a combination of pertuzumab, trastuzumab, and hyaluronidase. Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Pertuzumab has an approximate molecular weight of 148 kDa. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Trastuzumab has a molecular weight of approximately 148 kDa. Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by mammalian (Chinese Hamster Ovary) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa. PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection is a sterile, preservative-free, clear to opalescent, and colorless to slightly brownish solution supplied in single-dose vials for subcutaneous administration. PHESGO injection is supplied as two different configurations: 1 PHESGO is supplied in a 15 mL single-dose vial containing 1,200 mg of pertuzumab, 600 mg of trastuzumab, and 30,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (6.75 mg), L-histidine hydrochloric monohydrate (53.7 mg), L-methionine (22.4 mg), polysorbate 20 (6 mg), and sucrose (685 mg) with a pH of 5.5., 2 PHESGO is supplied in a 10 mL single-dose vial containing 600 mg of pertuzumab, 600 mg of trastuzumab, and 20,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (4.4 mg), L-histidine hydrochloric monohydrate (36.1 mg), L-methionine (14.9 mg), polysorbate 20 (4 mg), and sucrose (342 mg) with a pH of 5.5.</Description>
</NDC>
<NDC>
<NDCCode>50242-260-86</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50242-260-86) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50242-0260-86</NDC11Code>
<ProductNDC>50242-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phesgo</ProprietaryName>
<NonProprietaryName>Pertuzumab, Trastuzumab, And Hyaluronidase-zzxf</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200629</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761170</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>PERTUZUMAB; TRASTUZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)</SubstanceName>
<StrengthNumber>600; 600; 20000</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; U/10mL</StrengthUnit>
<Pharm_Classes>Endoglycosidase [EPC], Glycoside Hydrolases [CS], HER2/Neu/cerbB2 Antagonists [MoA], HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC], HER2/neu Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210503</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for: 1 Use in combination with chemotherapy as:neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. (1.1)adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (1.1), 2 Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. (1.2).</IndicationAndUsage>
<Description>PHESGO is a combination of pertuzumab, trastuzumab, and hyaluronidase. Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Pertuzumab has an approximate molecular weight of 148 kDa. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Trastuzumab has a molecular weight of approximately 148 kDa. Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by mammalian (Chinese Hamster Ovary) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa. PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection is a sterile, preservative-free, clear to opalescent, and colorless to slightly brownish solution supplied in single-dose vials for subcutaneous administration. PHESGO injection is supplied as two different configurations: 1 PHESGO is supplied in a 15 mL single-dose vial containing 1,200 mg of pertuzumab, 600 mg of trastuzumab, and 30,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (6.75 mg), L-histidine hydrochloric monohydrate (53.7 mg), L-methionine (22.4 mg), polysorbate 20 (6 mg), and sucrose (685 mg) with a pH of 5.5., 2 PHESGO is supplied in a 10 mL single-dose vial containing 600 mg of pertuzumab, 600 mg of trastuzumab, and 20,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (4.4 mg), L-histidine hydrochloric monohydrate (36.1 mg), L-methionine (14.9 mg), polysorbate 20 (4 mg), and sucrose (342 mg) with a pH of 5.5.</Description>
</NDC>
<NDC>
<NDCCode>50474-983-86</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (50474-983-86) / 6 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>50474-0983-86</NDC11Code>
<ProductNDC>50474-983</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rystiggo</ProprietaryName>
<NonProprietaryName>Rozanolixizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240614</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761286</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>ROZANOLIXIZUMAB</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neonatal Fc Receptor Blocker [EPC], Neonatal Fc Receptor Blockers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RYSTIGGO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.</IndicationAndUsage>
<Description>Rozanolixizumab-noli, a neonatal Fc receptor blocker, is a recombinant, humanized IgG4P monoclonal antibody, expressed in a genetically engineered Chinese hamster ovary DG44 cell line. Rozanolixizumab-noli has an approximate molecular weight of 148 kDa.</Description>
</NDC>
<NDC>
<NDCCode>51759-208-13</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (51759-208-13) / 30 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>51759-0208-13</NDC11Code>
<ProductNDC>51759-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epysqli</ProprietaryName>
<NonProprietaryName>Eculizumab-aagh</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250407</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761340</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ECULIZUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Complement Inhibitor [EPC], Complement Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPYSQLI is a complement inhibitor indicated for: 1 the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. (1.1), 2 the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. (1.2)Limitation of UseEPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS)., 3 the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. (1.3), 4 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.4).</IndicationAndUsage>
<Description>Eculizumab-aagh, a complement inhibitor, is a recombinant humanized monoclonal IgG2/4κ antibody produced in a Chinese Hamster Ovary cell line expression system and purified by standard bioprocess technology . Eculizumab-aagh contains human constant regions from human IgG2 sequences and human IgG4 sequences and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions. Eculizumab-aagh is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa. EPYSQLI (eculizumab-aagh) injection is a sterile, preservative-free, clear to slightly opalescent and colorless solution for intravenous infusion and is supplied in a 30 mL single-dose vial. Each mL contains 10 mg of eculizumab-aagh, dibasic sodium phosphate (0.77 mg), monobasic sodium phosphate (0.55 mg), polysorbate 80 (0.22 mg) (vegetable origin), trehalose (86 mg), and Water for Injection, USP. The pH is 7.</Description>
</NDC>
<NDC>
<NDCCode>71202-010-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (71202-010-01) / 30 mL in 1 VIAL, SINGLE-DOSE (71202-010-07) </PackageDescription>
<NDC11Code>71202-0010-01</NDC11Code>
<ProductNDC>71202-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epysqli</ProprietaryName>
<NonProprietaryName>Eculizumab-aagh</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250301</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761340</ApplicationNumber>
<LabelerName>Samsung Bioepis Co., Ltd.</LabelerName>
<SubstanceName>ECULIZUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Complement Inhibitor [EPC], Complement Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPYSQLI is a complement inhibitor indicated for: 1 the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. (1.1), 2 the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. (1.2)Limitation of UseEPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS)., 3 the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. (1.3).</IndicationAndUsage>
<Description>Eculizumab-aagh, a complement inhibitor, is a recombinant humanized monoclonal IgG2/4ϰ antibody produced in a Chinese Hamster Ovary cell line expression system and purified by standard bioprocess technology . Eculizumab-aagh contains human constant regions from human IgG2 sequences and human IgG4 sequences and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions. Eculizumab-aagh is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa. EPYSQLI (eculizumab-aagh) injection is a sterile, preservative-free, clear to slightly opalescent and colorless solution for intravenous infusion and is supplied in a 30 mL single-dose vial. Each mL contains 10 mg of eculizumab-aagh, dibasic sodium phosphate (0.77 mg), monobasic sodium phosphate (0.55 mg), polysorbate 80 (0.22 mg) (vegetable origin), trehalose (86 mg), and Water for Injection, USP. The pH is 7.</Description>
</NDC>
<NDC>
<NDCCode>62756-001-11</NDCCode>
<PackageDescription>25 kg in 1 DRUM (62756-001-11) </PackageDescription>
<NDC11Code>62756-0001-11</NDC11Code>
<ProductNDC>62756-001</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tofacitinib Citrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160404</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SUN PHARMACEUTICAL INDUSTRIES, INC.</LabelerName>
<SubstanceName>TOFACITINIB CITRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-24</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-NOV-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>62756-008-60</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (62756-008-60) > 1 BAG in 1 POUCH > 130 mL in 1 BAG</PackageDescription>
<NDC11Code>62756-0008-60</NDC11Code>
<ProductNDC>62756-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Infugem</ProprietaryName>
<NonProprietaryName>Gemcitabine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208313</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62756-009-30</NDCCode>
<PackageDescription>1 kg in 1 DRUM (62756-009-30) </PackageDescription>
<NDC11Code>62756-0009-30</NDC11Code>
<ProductNDC>62756-009</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bendamustine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20210111</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SUN PHARMACEUTICAL INDUSTRIES, INC.</LabelerName>
<SubstanceName>BENDAMUSTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-JAN-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>62756-010-14</NDCCode>
<PackageDescription>1 kg in 1 DRUM (62756-010-14) </PackageDescription>
<NDC11Code>62756-0010-14</NDC11Code>
<ProductNDC>62756-010</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Febuxostat</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20210111</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SUN PHARMACEUTICAL INDUSTRIES, INC.</LabelerName>
<SubstanceName>FEBUXOSTAT</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-JAN-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>62756-011-25</NDCCode>
<PackageDescription>25 kg in 1 DRUM (62756-011-25)</PackageDescription>
<NDC11Code>62756-0011-25</NDC11Code>
<ProductNDC>62756-011</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Estradiol Cypionate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20091218</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>ESTRADIOL CYPIONATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62756-012-11</NDCCode>
<PackageDescription>25 kg in 1 DRUM (62756-012-11)</PackageDescription>
<NDC11Code>62756-0012-11</NDC11Code>
<ProductNDC>62756-012</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Clindamycin Palmitate Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20091222</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>CLINDAMYCIN PALMITATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62756-014-26</NDCCode>
<PackageDescription>25 g in 1 BOTTLE, GLASS (62756-014-26)</PackageDescription>
<NDC11Code>62756-0014-26</NDC11Code>
<ProductNDC>62756-014</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lubiprostone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20100114</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>LUBIPROSTONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/25g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>