{
"NDC": [
{
"NDCCode": "65162-836-14",
"PackageDescription": "1 TUBE in 1 CARTON (65162-836-14) / 5 g in 1 TUBE",
"NDC11Code": "65162-0836-14",
"ProductNDC": "65162-836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208766",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201111",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir cream, 5% is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.",
"Description": "Acyclovir, USP is a synthetic deoxynucleoside analogue active against herpes viruses. Acyclovir cream, 5% is a formulation for topical administration. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. Acyclovir, USP is a white to off-white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir, USP are 2.27 and 9.25. Each gram of acyclovir cream, contains 50 mg (equivalent to 5% w/w) of acyclovir, USP and the following inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, purified water, sodium lauryl sulfate, and white petrolatum."
},
{
"NDCCode": "65162-037-28",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (65162-037-28) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "65162-0037-28",
"ProductNDC": "65162-037",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207342",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180727",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "65162-801-14",
"PackageDescription": "1 BOTTLE in 1 CARTON (65162-801-14) / 14 CAPSULE in 1 BOTTLE",
"NDC11Code": "65162-0801-14",
"ProductNDC": "65162-801",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203691",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150403",
"SamplePackage": "N",
"IndicationAndUsage": "Temozolomide capsules are an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1).",
"Description": "Temozolomide, USP is an alkylating drug. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide, USP is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for temozolomide capsules, USP are as follows: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid. The body of the capsules are made of gelatin and titanium dioxide, and are white opaque color. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac. Temozolomide Capsules USP, 5 mg: The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide. Temozolomide Capsules USP, 20 mg: The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide. Temozolomide Capsules USP, 100 mg: The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 140 mg: The blue cap contains FD&C Blue #1, gelatin and titanium dioxide. Temozolomide Capsules USP, 180 mg: The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 250 mg: The white cap contains gelatin and titanium dioxide."
},
{
"NDCCode": "65162-802-14",
"PackageDescription": "1 BOTTLE in 1 CARTON (65162-802-14) / 14 CAPSULE in 1 BOTTLE",
"NDC11Code": "65162-0802-14",
"ProductNDC": "65162-802",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203691",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150403",
"SamplePackage": "N",
"IndicationAndUsage": "Temozolomide capsules are an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1).",
"Description": "Temozolomide, USP is an alkylating drug. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide, USP is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for temozolomide capsules, USP are as follows: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid. The body of the capsules are made of gelatin and titanium dioxide, and are white opaque color. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac. Temozolomide Capsules USP, 5 mg: The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide. Temozolomide Capsules USP, 20 mg: The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide. Temozolomide Capsules USP, 100 mg: The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 140 mg: The blue cap contains FD&C Blue #1, gelatin and titanium dioxide. Temozolomide Capsules USP, 180 mg: The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 250 mg: The white cap contains gelatin and titanium dioxide."
},
{
"NDCCode": "65162-803-14",
"PackageDescription": "1 BOTTLE in 1 CARTON (65162-803-14) / 14 CAPSULE in 1 BOTTLE",
"NDC11Code": "65162-0803-14",
"ProductNDC": "65162-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203691",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150403",
"SamplePackage": "N",
"IndicationAndUsage": "Temozolomide capsules are an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1).",
"Description": "Temozolomide, USP is an alkylating drug. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide, USP is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for temozolomide capsules, USP are as follows: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid. The body of the capsules are made of gelatin and titanium dioxide, and are white opaque color. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac. Temozolomide Capsules USP, 5 mg: The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide. Temozolomide Capsules USP, 20 mg: The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide. Temozolomide Capsules USP, 100 mg: The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 140 mg: The blue cap contains FD&C Blue #1, gelatin and titanium dioxide. Temozolomide Capsules USP, 180 mg: The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 250 mg: The white cap contains gelatin and titanium dioxide."
},
{
"NDCCode": "65162-804-14",
"PackageDescription": "1 BOTTLE in 1 CARTON (65162-804-14) / 14 CAPSULE in 1 BOTTLE",
"NDC11Code": "65162-0804-14",
"ProductNDC": "65162-804",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203691",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "140",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150403",
"SamplePackage": "N",
"IndicationAndUsage": "Temozolomide capsules are an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1).",
"Description": "Temozolomide, USP is an alkylating drug. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide, USP is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for temozolomide capsules, USP are as follows: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid. The body of the capsules are made of gelatin and titanium dioxide, and are white opaque color. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac. Temozolomide Capsules USP, 5 mg: The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide. Temozolomide Capsules USP, 20 mg: The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide. Temozolomide Capsules USP, 100 mg: The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 140 mg: The blue cap contains FD&C Blue #1, gelatin and titanium dioxide. Temozolomide Capsules USP, 180 mg: The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 250 mg: The white cap contains gelatin and titanium dioxide."
},
{
"NDCCode": "65162-805-14",
"PackageDescription": "1 BOTTLE in 1 CARTON (65162-805-14) / 14 CAPSULE in 1 BOTTLE",
"NDC11Code": "65162-0805-14",
"ProductNDC": "65162-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203691",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150403",
"SamplePackage": "N",
"IndicationAndUsage": "Temozolomide capsules are an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1).",
"Description": "Temozolomide, USP is an alkylating drug. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide, USP is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for temozolomide capsules, USP are as follows: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid. The body of the capsules are made of gelatin and titanium dioxide, and are white opaque color. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac. Temozolomide Capsules USP, 5 mg: The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide. Temozolomide Capsules USP, 20 mg: The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide. Temozolomide Capsules USP, 100 mg: The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 140 mg: The blue cap contains FD&C Blue #1, gelatin and titanium dioxide. Temozolomide Capsules USP, 180 mg: The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 250 mg: The white cap contains gelatin and titanium dioxide."
},
{
"NDCCode": "14593-836-01",
"PackageDescription": "5 kg in 1 JAR (14593-836-01) ",
"NDC11Code": "14593-0836-01",
"ProductNDC": "14593-836",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Zoledronic Acid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20220214",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Emcure Pharmaceuticals Limited",
"SubstanceName": "ZOLEDRONIC ACID",
"StrengthNumber": "5",
"StrengthUnit": "kg/5kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-27",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "14-FEB-22"
},
{
"NDCCode": "14593-836-02",
"PackageDescription": "15 kg in 1 DRUM (14593-836-02) ",
"NDC11Code": "14593-0836-02",
"ProductNDC": "14593-836",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Zoledronic Acid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20220214",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Emcure Pharmaceuticals Limited",
"SubstanceName": "ZOLEDRONIC ACID",
"StrengthNumber": "5",
"StrengthUnit": "kg/5kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-27",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "14-FEB-22"
},
{
"NDCCode": "14593-836-03",
"PackageDescription": "50 kg in 1 DRUM (14593-836-03) ",
"NDC11Code": "14593-0836-03",
"ProductNDC": "14593-836",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Zoledronic Acid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20220214",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Emcure Pharmaceuticals Limited",
"SubstanceName": "ZOLEDRONIC ACID",
"StrengthNumber": "5",
"StrengthUnit": "kg/5kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-27",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "14-FEB-22"
},
{
"NDCCode": "16714-836-01",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (16714-836-01) ",
"NDC11Code": "16714-0836-01",
"ProductNDC": "16714-836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone",
"NonProprietaryName": "Ziprasidone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077565",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180726",
"SamplePackage": "N",
"IndicationAndUsage": "Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].",
"Description": "Ziprasidone capsules, USP contains the active moiety, ziprasidone in the form of ziprasidone hydrochloride, USP salt. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. Ziprasidone capsules, USP contain a hydrochloride salt of ziprasidone. Chemically, ziprasidone hydrochloride USP is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, hydrochloride. The molecular formula is C21H21ClN4OS · HCl and its molecular weight is 449.40. Ziprasidone hydrochloride, USP is a light pink to pink colored powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg, 40 mg, 60 mg, and 80 mg capsules. Ziprasidone capsules, USP contain ziprasidone hydrochloride USP, anhydrous lactose, magnesium stearate, polysorbate 80, povidone (PVK-30), pregelatinized starch and silicon dioxide. The components of the capsule shells are FD&C Blue #1, FD&C Red #3, gelatin, red iron oxide and titanium dioxide. The capsule shells are imprinted with black ink. The components of black ink (Black SW-9008/SW-9009) are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Ziprasidone capsules meets USP Dissolution Test 3."
},
{
"NDCCode": "51407-836-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (51407-836-05) ",
"NDC11Code": "51407-0836-05",
"ProductNDC": "51407-836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lurasidone Hydrochloride",
"NonProprietaryName": "Lurasidone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208058",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "LURASIDONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240203",
"SamplePackage": "N",
"IndicationAndUsage": "Lurasidone hydrochloride tablet is indicated for: 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)] . , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)] . , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)] . .",
"Description": "Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are: croscarmellose sodium, hypromellose, magnesium stearate, mannitol, polyethylene glycol, pregelatinized starch and titanium dioxide."
},
{
"NDCCode": "60687-836-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (60687-836-01) / 1 TABLET in 1 BLISTER PACK (60687-836-11) ",
"NDC11Code": "60687-0836-01",
"ProductNDC": "60687-836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074260",
"LabelerName": "American Health Packaging",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240316",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths: 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake."
},
{
"NDCCode": "66039-836-03",
"PackageDescription": "50 kg in 1 DRUM (66039-836-03) ",
"NDC11Code": "66039-0836-03",
"ProductNDC": "66039-836",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tazarotene",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080314",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Alivus Life Sciences Limited",
"SubstanceName": "TAZAROTENE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-02-10",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "14-MAR-08"
},
{
"NDCCode": "65162-023-09",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (65162-023-09) ",
"NDC11Code": "65162-0023-09",
"ProductNDC": "65162-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230828",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, isopropyl alcohol, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "65162-024-09",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (65162-024-09) ",
"NDC11Code": "65162-0024-09",
"ProductNDC": "65162-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230828",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, isopropyl alcohol, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "65162-025-09",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (65162-025-09) ",
"NDC11Code": "65162-0025-09",
"ProductNDC": "65162-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230828",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, isopropyl alcohol, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "65162-026-09",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (65162-026-09) ",
"NDC11Code": "65162-0026-09",
"ProductNDC": "65162-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230828",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, isopropyl alcohol, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "65162-027-09",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (65162-027-09) ",
"NDC11Code": "65162-0027-09",
"ProductNDC": "65162-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230828",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, isopropyl alcohol, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "65162-028-09",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (65162-028-09) ",
"NDC11Code": "65162-0028-09",
"ProductNDC": "65162-028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230828",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, isopropyl alcohol, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "65162-047-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (65162-047-03) ",
"NDC11Code": "65162-0047-03",
"ProductNDC": "65162-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203638",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121030",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "65162-047-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (65162-047-10) ",
"NDC11Code": "65162-0047-10",
"ProductNDC": "65162-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203638",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121030",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "65162-047-25",
"PackageDescription": "250 TABLET in 1 BOTTLE (65162-047-25) ",
"NDC11Code": "65162-0047-25",
"ProductNDC": "65162-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203638",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121030",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "65162-047-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (65162-047-50) ",
"NDC11Code": "65162-0047-50",
"ProductNDC": "65162-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203638",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121030",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "65162-048-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (65162-048-03) ",
"NDC11Code": "65162-0048-03",
"ProductNDC": "65162-048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203638",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121030",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "65162-048-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (65162-048-10) ",
"NDC11Code": "65162-0048-10",
"ProductNDC": "65162-048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203638",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121030",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "65162-048-25",
"PackageDescription": "250 TABLET in 1 BOTTLE (65162-048-25) ",
"NDC11Code": "65162-0048-25",
"ProductNDC": "65162-048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203638",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121030",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "65162-049-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (65162-049-03) ",
"NDC11Code": "65162-0049-03",
"ProductNDC": "65162-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203638",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121030",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "65162-049-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (65162-049-10) ",
"NDC11Code": "65162-0049-10",
"ProductNDC": "65162-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203638",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121030",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "65162-049-25",
"PackageDescription": "250 TABLET in 1 BOTTLE (65162-049-25) ",
"NDC11Code": "65162-0049-25",
"ProductNDC": "65162-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203638",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121030",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
}
]
}
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<NDCList>
<NDC>
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<PackageDescription>1 TUBE in 1 CARTON (65162-836-14) / 5 g in 1 TUBE</PackageDescription>
<NDC11Code>65162-0836-14</NDC11Code>
<ProductNDC>65162-836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
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<DosageFormName>CREAM</DosageFormName>
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<StartMarketingDate>20201111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208766</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir cream, 5% is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic deoxynucleoside analogue active against herpes viruses. Acyclovir cream, 5% is a formulation for topical administration. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. Acyclovir, USP is a white to off-white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir, USP are 2.27 and 9.25. Each gram of acyclovir cream, contains 50 mg (equivalent to 5% w/w) of acyclovir, USP and the following inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, purified water, sodium lauryl sulfate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>65162-037-28</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (65162-037-28) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65162-0037-28</NDC11Code>
<ProductNDC>65162-037</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guaifenesin</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207342</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65162-801-14</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65162-801-14) / 14 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>65162-0801-14</NDC11Code>
<ProductNDC>65162-801</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203691</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temozolomide capsules are an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1).</IndicationAndUsage>
<Description>Temozolomide, USP is an alkylating drug. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide, USP is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for temozolomide capsules, USP are as follows: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid. The body of the capsules are made of gelatin and titanium dioxide, and are white opaque color. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac. Temozolomide Capsules USP, 5 mg: The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide. Temozolomide Capsules USP, 20 mg: The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide. Temozolomide Capsules USP, 100 mg: The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 140 mg: The blue cap contains FD&C Blue #1, gelatin and titanium dioxide. Temozolomide Capsules USP, 180 mg: The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 250 mg: The white cap contains gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65162-802-14</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65162-802-14) / 14 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>65162-0802-14</NDC11Code>
<ProductNDC>65162-802</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203691</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temozolomide capsules are an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1).</IndicationAndUsage>
<Description>Temozolomide, USP is an alkylating drug. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide, USP is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for temozolomide capsules, USP are as follows: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid. The body of the capsules are made of gelatin and titanium dioxide, and are white opaque color. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac. Temozolomide Capsules USP, 5 mg: The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide. Temozolomide Capsules USP, 20 mg: The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide. Temozolomide Capsules USP, 100 mg: The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 140 mg: The blue cap contains FD&C Blue #1, gelatin and titanium dioxide. Temozolomide Capsules USP, 180 mg: The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 250 mg: The white cap contains gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65162-803-14</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65162-803-14) / 14 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>65162-0803-14</NDC11Code>
<ProductNDC>65162-803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203691</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temozolomide capsules are an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1).</IndicationAndUsage>
<Description>Temozolomide, USP is an alkylating drug. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide, USP is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for temozolomide capsules, USP are as follows: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid. The body of the capsules are made of gelatin and titanium dioxide, and are white opaque color. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac. Temozolomide Capsules USP, 5 mg: The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide. Temozolomide Capsules USP, 20 mg: The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide. Temozolomide Capsules USP, 100 mg: The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 140 mg: The blue cap contains FD&C Blue #1, gelatin and titanium dioxide. Temozolomide Capsules USP, 180 mg: The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 250 mg: The white cap contains gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65162-804-14</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65162-804-14) / 14 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>65162-0804-14</NDC11Code>
<ProductNDC>65162-804</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203691</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temozolomide capsules are an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1).</IndicationAndUsage>
<Description>Temozolomide, USP is an alkylating drug. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide, USP is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for temozolomide capsules, USP are as follows: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid. The body of the capsules are made of gelatin and titanium dioxide, and are white opaque color. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac. Temozolomide Capsules USP, 5 mg: The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide. Temozolomide Capsules USP, 20 mg: The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide. Temozolomide Capsules USP, 100 mg: The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 140 mg: The blue cap contains FD&C Blue #1, gelatin and titanium dioxide. Temozolomide Capsules USP, 180 mg: The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 250 mg: The white cap contains gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65162-805-14</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65162-805-14) / 14 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>65162-0805-14</NDC11Code>
<ProductNDC>65162-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203691</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temozolomide capsules are an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1).</IndicationAndUsage>
<Description>Temozolomide, USP is an alkylating drug. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide, USP is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for temozolomide capsules, USP are as follows: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid. The body of the capsules are made of gelatin and titanium dioxide, and are white opaque color. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac. Temozolomide Capsules USP, 5 mg: The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide. Temozolomide Capsules USP, 20 mg: The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide. Temozolomide Capsules USP, 100 mg: The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 140 mg: The blue cap contains FD&C Blue #1, gelatin and titanium dioxide. Temozolomide Capsules USP, 180 mg: The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 250 mg: The white cap contains gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>14593-836-01</NDCCode>
<PackageDescription>5 kg in 1 JAR (14593-836-01) </PackageDescription>
<NDC11Code>14593-0836-01</NDC11Code>
<ProductNDC>14593-836</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zoledronic Acid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20220214</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
<SubstanceName>ZOLEDRONIC ACID</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>kg/5kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-27</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-FEB-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14593-836-02</NDCCode>
<PackageDescription>15 kg in 1 DRUM (14593-836-02) </PackageDescription>
<NDC11Code>14593-0836-02</NDC11Code>
<ProductNDC>14593-836</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zoledronic Acid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20220214</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
<SubstanceName>ZOLEDRONIC ACID</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>kg/5kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-27</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-FEB-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14593-836-03</NDCCode>
<PackageDescription>50 kg in 1 DRUM (14593-836-03) </PackageDescription>
<NDC11Code>14593-0836-03</NDC11Code>
<ProductNDC>14593-836</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zoledronic Acid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20220214</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
<SubstanceName>ZOLEDRONIC ACID</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>kg/5kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-27</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-FEB-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>16714-836-01</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (16714-836-01) </PackageDescription>
<NDC11Code>16714-0836-01</NDC11Code>
<ProductNDC>16714-836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone</ProprietaryName>
<NonProprietaryName>Ziprasidone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077565</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>Ziprasidone capsules, USP contains the active moiety, ziprasidone in the form of ziprasidone hydrochloride, USP salt. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. Ziprasidone capsules, USP contain a hydrochloride salt of ziprasidone. Chemically, ziprasidone hydrochloride USP is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, hydrochloride. The molecular formula is C21H21ClN4OS · HCl and its molecular weight is 449.40. Ziprasidone hydrochloride, USP is a light pink to pink colored powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg, 40 mg, 60 mg, and 80 mg capsules. Ziprasidone capsules, USP contain ziprasidone hydrochloride USP, anhydrous lactose, magnesium stearate, polysorbate 80, povidone (PVK-30), pregelatinized starch and silicon dioxide. The components of the capsule shells are FD&C Blue #1, FD&C Red #3, gelatin, red iron oxide and titanium dioxide. The capsule shells are imprinted with black ink. The components of black ink (Black SW-9008/SW-9009) are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Ziprasidone capsules meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>51407-836-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (51407-836-05) </PackageDescription>
<NDC11Code>51407-0836-05</NDC11Code>
<ProductNDC>51407-836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208058</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lurasidone hydrochloride tablet is indicated for: 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)] . , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)] . , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)] . .</IndicationAndUsage>
<Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are: croscarmellose sodium, hypromellose, magnesium stearate, mannitol, polyethylene glycol, pregelatinized starch and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>60687-836-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (60687-836-01) / 1 TABLET in 1 BLISTER PACK (60687-836-11) </PackageDescription>
<NDC11Code>60687-0836-01</NDC11Code>
<ProductNDC>60687-836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074260</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths: 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>66039-836-03</NDCCode>
<PackageDescription>50 kg in 1 DRUM (66039-836-03) </PackageDescription>
<NDC11Code>66039-0836-03</NDC11Code>
<ProductNDC>66039-836</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tazarotene</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20080314</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Alivus Life Sciences Limited</LabelerName>
<SubstanceName>TAZAROTENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-02-10</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-MAR-08</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65162-023-09</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (65162-023-09) </PackageDescription>
<NDC11Code>65162-0023-09</NDC11Code>
<ProductNDC>65162-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, isopropyl alcohol, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>65162-024-09</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (65162-024-09) </PackageDescription>
<NDC11Code>65162-0024-09</NDC11Code>
<ProductNDC>65162-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, isopropyl alcohol, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>65162-025-09</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (65162-025-09) </PackageDescription>
<NDC11Code>65162-0025-09</NDC11Code>
<ProductNDC>65162-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, isopropyl alcohol, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>65162-026-09</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (65162-026-09) </PackageDescription>
<NDC11Code>65162-0026-09</NDC11Code>
<ProductNDC>65162-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, isopropyl alcohol, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>65162-027-09</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (65162-027-09) </PackageDescription>
<NDC11Code>65162-0027-09</NDC11Code>
<ProductNDC>65162-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, isopropyl alcohol, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>65162-028-09</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (65162-028-09) </PackageDescription>
<NDC11Code>65162-0028-09</NDC11Code>
<ProductNDC>65162-028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, isopropyl alcohol, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>65162-047-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (65162-047-03) </PackageDescription>
<NDC11Code>65162-0047-03</NDC11Code>
<ProductNDC>65162-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203638</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>65162-047-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (65162-047-10) </PackageDescription>
<NDC11Code>65162-0047-10</NDC11Code>
<ProductNDC>65162-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203638</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>65162-047-25</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE (65162-047-25) </PackageDescription>
<NDC11Code>65162-0047-25</NDC11Code>
<ProductNDC>65162-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203638</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>65162-047-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (65162-047-50) </PackageDescription>
<NDC11Code>65162-0047-50</NDC11Code>
<ProductNDC>65162-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203638</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>65162-048-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (65162-048-03) </PackageDescription>
<NDC11Code>65162-0048-03</NDC11Code>
<ProductNDC>65162-048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203638</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>65162-048-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (65162-048-10) </PackageDescription>
<NDC11Code>65162-0048-10</NDC11Code>
<ProductNDC>65162-048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203638</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>65162-048-25</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE (65162-048-25) </PackageDescription>
<NDC11Code>65162-0048-25</NDC11Code>
<ProductNDC>65162-048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203638</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>65162-049-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (65162-049-03) </PackageDescription>
<NDC11Code>65162-0049-03</NDC11Code>
<ProductNDC>65162-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203638</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>65162-049-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (65162-049-10) </PackageDescription>
<NDC11Code>65162-0049-10</NDC11Code>
<ProductNDC>65162-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203638</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>65162-049-25</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE (65162-049-25) </PackageDescription>
<NDC11Code>65162-0049-25</NDC11Code>
<ProductNDC>65162-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203638</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
</NDCList>