{
"NDC": [
{
"NDCCode": "16729-148-21",
"PackageDescription": "4000 TABLET, FILM COATED in 1 CONTAINER (16729-148-21) ",
"NDC11Code": "16729-0148-21",
"ProductNDC": "16729-148",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20151216",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-11-08",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "16-DEC-15"
},
{
"NDCCode": "16729-695-06",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (16729-695-06) ",
"NDC11Code": "16729-0695-06",
"ProductNDC": "16729-695",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lenalidomide",
"NonProprietaryName": "Lenalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218872",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "LENALIDOMIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260302",
"SamplePackage": "N",
"IndicationAndUsage": "Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone ( 1.1). , 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1). , 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2). , 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3). , 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4). , 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5). .",
"Description": "Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C 13H 13N 3O 3,and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide, green and black ink. The 2.5 mg contains gelatin, iron oxide black, titanium dioxide, green and black ink. The 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide, green and black ink. The 15 mg capsule shell contains gelatin, iron oxide red, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, green and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, green and black ink. The black imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol and shellac. The green imprinting ink contains FD&C Blue #2 aluminum lake, iron oxide yellow, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "16729-696-06",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (16729-696-06) ",
"NDC11Code": "16729-0696-06",
"ProductNDC": "16729-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lenalidomide",
"NonProprietaryName": "Lenalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218872",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "LENALIDOMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260226",
"SamplePackage": "N",
"IndicationAndUsage": "Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone ( 1.1). , 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1). , 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2). , 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3). , 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4). , 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5). .",
"Description": "Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C 13H 13N 3O 3,and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide, green and black ink. The 2.5 mg contains gelatin, iron oxide black, titanium dioxide, green and black ink. The 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide, green and black ink. The 15 mg capsule shell contains gelatin, iron oxide red, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, green and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, green and black ink. The black imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol and shellac. The green imprinting ink contains FD&C Blue #2 aluminum lake, iron oxide yellow, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "16729-697-06",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (16729-697-06) ",
"NDC11Code": "16729-0697-06",
"ProductNDC": "16729-697",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lenalidomide",
"NonProprietaryName": "Lenalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218872",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "LENALIDOMIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260408",
"SamplePackage": "N",
"IndicationAndUsage": "Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone ( 1.1). , 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1). , 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2). , 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3). , 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4). , 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5). .",
"Description": "Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C 13H 13N 3O 3,and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide, green and black ink. The 2.5 mg contains gelatin, iron oxide black, titanium dioxide, green and black ink. The 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide, green and black ink. The 15 mg capsule shell contains gelatin, iron oxide red, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, green and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, green and black ink. The black imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol and shellac. The green imprinting ink contains FD&C Blue #2 aluminum lake, iron oxide yellow, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "16729-148-00",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16729-148-00)",
"NDC11Code": "16729-0148-00",
"ProductNDC": "16729-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202152",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-04-04"
},
{
"NDCCode": "16729-148-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16729-148-01) ",
"NDC11Code": "16729-0148-01",
"ProductNDC": "16729-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202152",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150721",
"SamplePackage": "N",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablet, USP is supplied for oral administration as 25 mg (round, pink), 50 mg (round, white to off white), 100 mg (round, yellow), 200 mg (round, white to off white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains quetiapine fumarate, USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains quetiapine fumarate, USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains quetiapine fumarate, USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains quetiapine fumarate, USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "16729-148-10",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16729-148-10)",
"NDC11Code": "16729-0148-10",
"ProductNDC": "16729-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202152",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "16729-148-17",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (16729-148-17) ",
"NDC11Code": "16729-0148-17",
"ProductNDC": "16729-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202152",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120328",
"SamplePackage": "N",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablet, USP is supplied for oral administration as 25 mg (round, pink), 50 mg (round, white to off white), 100 mg (round, yellow), 200 mg (round, white to off white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains quetiapine fumarate, USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains quetiapine fumarate, USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains quetiapine fumarate, USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains quetiapine fumarate, USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "0024-5801-21",
"PackageDescription": "148 mL in 1 BOTTLE, PLASTIC (0024-5801-21)",
"NDC11Code": "00024-5801-21",
"ProductNDC": "0024-5801",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xyzal",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20080402",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022157",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-10-26",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0363-0366-21",
"PackageDescription": "148 mL in 1 BOTTLE, SPRAY (0363-0366-21) ",
"NDC11Code": "00363-0366-21",
"ProductNDC": "0363-0366",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Walgreens Broad Spectrum Spf 50 Body Oil Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240919",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "WALGREEN COMPANY",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 150; 50; 100",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-10-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240919",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "0955-1026-21",
"PackageDescription": "148 mL in 1 BOTTLE, PLASTIC (0955-1026-21)",
"NDC11Code": "00955-1026-21",
"ProductNDC": "0955-1026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levocetirizine Dihydrochloride",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20080402",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022157",
"LabelerName": "Winthrop U.S.",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-10-03",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "16364-148-21",
"PackageDescription": "4000 TABLET, FILM COATED in 1 CONTAINER (16364-148-21) ",
"NDC11Code": "16364-0148-21",
"ProductNDC": "16364-148",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20151216",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Intas Pharmaceuticals Limited",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-10-15",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "16-DEC-15"
},
{
"NDCCode": "37808-159-21",
"PackageDescription": "148 mL in 1 BOTTLE, SPRAY (37808-159-21) ",
"NDC11Code": "37808-0159-21",
"ProductNDC": "37808-159",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heb 50 Glow Body Oil Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240118",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "H.E.B.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 150; 50; 100",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240118",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "51862-148-03",
"PackageDescription": "3 POUCH in 1 CARTON (51862-148-03) / 21 d in 1 POUCH (51862-148-01) ",
"NDC11Code": "51862-0148-03",
"ProductNDC": "51862-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloette",
"NonProprietaryName": "Etonogestrel And Ethinyl Estradiol",
"DosageFormName": "INSERT, EXTENDED RELEASE",
"RouteName": "VAGINAL",
"StartMarketingDate": "20221201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211328",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "ETHINYL ESTRADIOL; ETONOGESTREL",
"StrengthNumber": ".015; .12",
"StrengthUnit": "mg/d; mg/d",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N",
"IndicationAndUsage": "FOR VAGINAL USE ONLY. Haloette® is indicated for use by females of reproductive age to prevent pregnancy.",
"Description": "Haloette (etonogestrel and ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Haloette is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. Haloette is not made with natural rubber latex. Haloette has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows."
},
{
"NDCCode": "59765-148-21",
"PackageDescription": "4000 TABLET, FILM COATED in 1 CONTAINER (59765-148-21) ",
"NDC11Code": "59765-0148-21",
"ProductNDC": "59765-148",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20151216",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Intas Pharmaceuticals Limited",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-10-15",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "16-DEC-15"
},
{
"NDCCode": "60687-148-21",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-148-21) > 1 TABLET in 1 BLISTER PACK (60687-148-11)",
"NDC11Code": "60687-0148-21",
"ProductNDC": "60687-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxymorphone Hydrochloride",
"NonProprietaryName": "Oxymorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151201",
"EndMarketingDate": "20180930",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021611",
"LabelerName": "American Health Packaging",
"SubstanceName": "OXYMORPHONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-10-02",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "66267-148-21",
"PackageDescription": "21 TABLET in 1 BOTTLE (66267-148-21) ",
"NDC11Code": "66267-0148-21",
"ProductNDC": "66267-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079067",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20161010",
"SamplePackage": "N"
},
{
"NDCCode": "67046-148-21",
"PackageDescription": "21 TABLET, FILM COATED in 1 BLISTER PACK (67046-148-21) ",
"NDC11Code": "67046-0148-21",
"ProductNDC": "67046-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Coupler Enterprises",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171005",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pK a of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-( 5H –dibenzo[ a, d]cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "16729-020-10",
"PackageDescription": "30 TABLET in 1 BOTTLE (16729-020-10) ",
"NDC11Code": "16729-0020-10",
"ProductNDC": "16729-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200044",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130213",
"SamplePackage": "N"
},
{
"NDCCode": "16729-021-10",
"PackageDescription": "30 TABLET in 1 BOTTLE (16729-021-10) ",
"NDC11Code": "16729-0021-10",
"ProductNDC": "16729-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200044",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130213",
"SamplePackage": "N"
},
{
"NDCCode": "16729-022-10",
"PackageDescription": "30 TABLET in 1 BOTTLE (16729-022-10) ",
"NDC11Code": "16729-0022-10",
"ProductNDC": "16729-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200044",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130213",
"SamplePackage": "N"
},
{
"NDCCode": "16729-041-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (16729-041-01) ",
"NDC11Code": "16729-0041-01",
"ProductNDC": "16729-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091195",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110930",
"SamplePackage": "N",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3 S-[3 R*[ E(1 S*,3 S*,4 S*)], 4 S*,5 R*,8 S*,9 E,12 R*,14 R*,15 S*,16 R*,18 S*,19 S*,26a R*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1- c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration containing 0.5 mg, 1 mg or 5 mg of tacrolimus. Inactive ingredients include lactose monohydrate, hypromellose E5, croscarmellose sodium, and magnesium stearate. The 0.5 mg capsule shell contains gelatin, titanium dioxide, iron oxide yellow and sodium lauryl sulfate, the 1 mg capsule shell contains gelatin, titanium dioxide and sodium lauryl sulfate, and the 5 mg capsule shell contains gelatin, titanium dioxide, iron oxide red and sodium lauryl sulfate."
},
{
"NDCCode": "16729-042-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (16729-042-01) ",
"NDC11Code": "16729-0042-01",
"ProductNDC": "16729-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091195",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110930",
"SamplePackage": "N",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3 S-[3 R*[ E(1 S*,3 S*,4 S*)], 4 S*,5 R*,8 S*,9 E,12 R*,14 R*,15 S*,16 R*,18 S*,19 S*,26a R*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1- c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration containing 0.5 mg, 1 mg or 5 mg of tacrolimus. Inactive ingredients include lactose monohydrate, hypromellose E5, croscarmellose sodium, and magnesium stearate. The 0.5 mg capsule shell contains gelatin, titanium dioxide, iron oxide yellow and sodium lauryl sulfate, the 1 mg capsule shell contains gelatin, titanium dioxide and sodium lauryl sulfate, and the 5 mg capsule shell contains gelatin, titanium dioxide, iron oxide red and sodium lauryl sulfate."
},
{
"NDCCode": "16729-043-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (16729-043-01) ",
"NDC11Code": "16729-0043-01",
"ProductNDC": "16729-043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091195",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110930",
"SamplePackage": "N",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3 S-[3 R*[ E(1 S*,3 S*,4 S*)], 4 S*,5 R*,8 S*,9 E,12 R*,14 R*,15 S*,16 R*,18 S*,19 S*,26a R*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1- c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration containing 0.5 mg, 1 mg or 5 mg of tacrolimus. Inactive ingredients include lactose monohydrate, hypromellose E5, croscarmellose sodium, and magnesium stearate. The 0.5 mg capsule shell contains gelatin, titanium dioxide, iron oxide yellow and sodium lauryl sulfate, the 1 mg capsule shell contains gelatin, titanium dioxide and sodium lauryl sulfate, and the 5 mg capsule shell contains gelatin, titanium dioxide, iron oxide red and sodium lauryl sulfate."
},
{
"NDCCode": "16729-064-16",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (16729-064-16) ",
"NDC11Code": "16729-0064-16",
"ProductNDC": "16729-064",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090843",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130523",
"SamplePackage": "N",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (white), 500 mg (yellow), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, povidone K-30, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 500 mg tablets: iron oxide yellow 750 mg tablets: FD& C yellow #6/sunset yellow FCF aluminum lake, iron oxide red."
},
{
"NDCCode": "16729-064-29",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (16729-064-29) ",
"NDC11Code": "16729-0064-29",
"ProductNDC": "16729-064",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090843",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130523",
"SamplePackage": "N",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (white), 500 mg (yellow), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, povidone K-30, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 500 mg tablets: iron oxide yellow 750 mg tablets: FD& C yellow #6/sunset yellow FCF aluminum lake, iron oxide red."
},
{
"NDCCode": "16729-065-16",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (16729-065-16) ",
"NDC11Code": "16729-0065-16",
"ProductNDC": "16729-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090843",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130531",
"SamplePackage": "N",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (white), 500 mg (yellow), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, povidone K-30, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 500 mg tablets: iron oxide yellow 750 mg tablets: FD& C yellow #6/sunset yellow FCF aluminum lake, iron oxide red."
},
{
"NDCCode": "16729-065-29",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (16729-065-29) ",
"NDC11Code": "16729-0065-29",
"ProductNDC": "16729-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090843",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130612",
"SamplePackage": "N",
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<NDC11Code>00024-5801-21</NDC11Code>
<ProductNDC>0024-5801</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xyzal</ProprietaryName>
<NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080402</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022157</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>LEVOCETIRIZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-26</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0363-0366-21</NDCCode>
<PackageDescription>148 mL in 1 BOTTLE, SPRAY (0363-0366-21) </PackageDescription>
<NDC11Code>00363-0366-21</NDC11Code>
<ProductNDC>0363-0366</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Walgreens Broad Spectrum Spf 50 Body Oil Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240919</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>WALGREEN COMPANY</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 150; 50; 100</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0955-1026-21</NDCCode>
<PackageDescription>148 mL in 1 BOTTLE, PLASTIC (0955-1026-21)</PackageDescription>
<NDC11Code>00955-1026-21</NDC11Code>
<ProductNDC>0955-1026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levocetirizine Dihydrochloride</ProprietaryName>
<NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080402</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022157</ApplicationNumber>
<LabelerName>Winthrop U.S.</LabelerName>
<SubstanceName>LEVOCETIRIZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-03</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16364-148-21</NDCCode>
<PackageDescription>4000 TABLET, FILM COATED in 1 CONTAINER (16364-148-21) </PackageDescription>
<NDC11Code>16364-0148-21</NDC11Code>
<ProductNDC>16364-148</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20151216</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Intas Pharmaceuticals Limited</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-10-15</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-DEC-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>37808-159-21</NDCCode>
<PackageDescription>148 mL in 1 BOTTLE, SPRAY (37808-159-21) </PackageDescription>
<NDC11Code>37808-0159-21</NDC11Code>
<ProductNDC>37808-159</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heb 50 Glow Body Oil Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>H.E.B.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 150; 50; 100</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51862-148-03</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (51862-148-03) / 21 d in 1 POUCH (51862-148-01) </PackageDescription>
<NDC11Code>51862-0148-03</NDC11Code>
<ProductNDC>51862-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloette</ProprietaryName>
<NonProprietaryName>Etonogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>INSERT, EXTENDED RELEASE</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20221201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211328</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>ETHINYL ESTRADIOL; ETONOGESTREL</SubstanceName>
<StrengthNumber>.015; .12</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR VAGINAL USE ONLY. Haloette® is indicated for use by females of reproductive age to prevent pregnancy.</IndicationAndUsage>
<Description>Haloette (etonogestrel and ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Haloette is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. Haloette is not made with natural rubber latex. Haloette has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows.</Description>
</NDC>
<NDC>
<NDCCode>59765-148-21</NDCCode>
<PackageDescription>4000 TABLET, FILM COATED in 1 CONTAINER (59765-148-21) </PackageDescription>
<NDC11Code>59765-0148-21</NDC11Code>
<ProductNDC>59765-148</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20151216</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Intas Pharmaceuticals Limited</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-10-15</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-DEC-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>60687-148-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-148-21) > 1 TABLET in 1 BLISTER PACK (60687-148-11)</PackageDescription>
<NDC11Code>60687-0148-21</NDC11Code>
<ProductNDC>60687-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151201</StartMarketingDate>
<EndMarketingDate>20180930</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021611</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-10-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>66267-148-21</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE (66267-148-21) </PackageDescription>
<NDC11Code>66267-0148-21</NDC11Code>
<ProductNDC>66267-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079067</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67046-148-21</NDCCode>
<PackageDescription>21 TABLET, FILM COATED in 1 BLISTER PACK (67046-148-21) </PackageDescription>
<NDC11Code>67046-0148-21</NDC11Code>
<ProductNDC>67046-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Coupler Enterprises</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pK a of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-( 5H –dibenzo[ a, d]cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>16729-020-10</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16729-020-10) </PackageDescription>
<NDC11Code>16729-0020-10</NDC11Code>
<ProductNDC>16729-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200044</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16729-021-10</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16729-021-10) </PackageDescription>
<NDC11Code>16729-0021-10</NDC11Code>
<ProductNDC>16729-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200044</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16729-022-10</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16729-022-10) </PackageDescription>
<NDC11Code>16729-0022-10</NDC11Code>
<ProductNDC>16729-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200044</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16729-041-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16729-041-01) </PackageDescription>
<NDC11Code>16729-0041-01</NDC11Code>
<ProductNDC>16729-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091195</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3 S-[3 R*[ E(1 S*,3 S*,4 S*)], 4 S*,5 R*,8 S*,9 E,12 R*,14 R*,15 S*,16 R*,18 S*,19 S*,26a R*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1- c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration containing 0.5 mg, 1 mg or 5 mg of tacrolimus. Inactive ingredients include lactose monohydrate, hypromellose E5, croscarmellose sodium, and magnesium stearate. The 0.5 mg capsule shell contains gelatin, titanium dioxide, iron oxide yellow and sodium lauryl sulfate, the 1 mg capsule shell contains gelatin, titanium dioxide and sodium lauryl sulfate, and the 5 mg capsule shell contains gelatin, titanium dioxide, iron oxide red and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>16729-042-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16729-042-01) </PackageDescription>
<NDC11Code>16729-0042-01</NDC11Code>
<ProductNDC>16729-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091195</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3 S-[3 R*[ E(1 S*,3 S*,4 S*)], 4 S*,5 R*,8 S*,9 E,12 R*,14 R*,15 S*,16 R*,18 S*,19 S*,26a R*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1- c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration containing 0.5 mg, 1 mg or 5 mg of tacrolimus. Inactive ingredients include lactose monohydrate, hypromellose E5, croscarmellose sodium, and magnesium stearate. The 0.5 mg capsule shell contains gelatin, titanium dioxide, iron oxide yellow and sodium lauryl sulfate, the 1 mg capsule shell contains gelatin, titanium dioxide and sodium lauryl sulfate, and the 5 mg capsule shell contains gelatin, titanium dioxide, iron oxide red and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>16729-043-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16729-043-01) </PackageDescription>
<NDC11Code>16729-0043-01</NDC11Code>
<ProductNDC>16729-043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091195</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3 S-[3 R*[ E(1 S*,3 S*,4 S*)], 4 S*,5 R*,8 S*,9 E,12 R*,14 R*,15 S*,16 R*,18 S*,19 S*,26a R*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1- c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration containing 0.5 mg, 1 mg or 5 mg of tacrolimus. Inactive ingredients include lactose monohydrate, hypromellose E5, croscarmellose sodium, and magnesium stearate. The 0.5 mg capsule shell contains gelatin, titanium dioxide, iron oxide yellow and sodium lauryl sulfate, the 1 mg capsule shell contains gelatin, titanium dioxide and sodium lauryl sulfate, and the 5 mg capsule shell contains gelatin, titanium dioxide, iron oxide red and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>16729-064-16</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16729-064-16) </PackageDescription>
<NDC11Code>16729-0064-16</NDC11Code>
<ProductNDC>16729-064</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090843</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (white), 500 mg (yellow), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, povidone K-30, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 500 mg tablets: iron oxide yellow 750 mg tablets: FD& C yellow #6/sunset yellow FCF aluminum lake, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>16729-064-29</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (16729-064-29) </PackageDescription>
<NDC11Code>16729-0064-29</NDC11Code>
<ProductNDC>16729-064</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090843</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (white), 500 mg (yellow), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, povidone K-30, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 500 mg tablets: iron oxide yellow 750 mg tablets: FD& C yellow #6/sunset yellow FCF aluminum lake, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>16729-065-16</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16729-065-16) </PackageDescription>
<NDC11Code>16729-0065-16</NDC11Code>
<ProductNDC>16729-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090843</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (white), 500 mg (yellow), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, povidone K-30, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 500 mg tablets: iron oxide yellow 750 mg tablets: FD& C yellow #6/sunset yellow FCF aluminum lake, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>16729-065-29</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (16729-065-29) </PackageDescription>
<NDC11Code>16729-0065-29</NDC11Code>
<ProductNDC>16729-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090843</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (white), 500 mg (yellow), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, povidone K-30, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 500 mg tablets: iron oxide yellow 750 mg tablets: FD& C yellow #6/sunset yellow FCF aluminum lake, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>16729-066-16</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16729-066-16) </PackageDescription>
<NDC11Code>16729-0066-16</NDC11Code>
<ProductNDC>16729-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090843</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (white), 500 mg (yellow), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, povidone K-30, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 500 mg tablets: iron oxide yellow 750 mg tablets: FD& C yellow #6/sunset yellow FCF aluminum lake, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>16729-066-29</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (16729-066-29) </PackageDescription>
<NDC11Code>16729-0066-29</NDC11Code>
<ProductNDC>16729-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090843</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (white), 500 mg (yellow), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, povidone K-30, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 500 mg tablets: iron oxide yellow 750 mg tablets: FD& C yellow #6/sunset yellow FCF aluminum lake, iron oxide red.</Description>
</NDC>
</NDCList>