{
"NDC": [
{
"NDCCode": "51552-0838-4",
"PackageDescription": "100 g in 1 CONTAINER (51552-0838-4) ",
"NDC11Code": "51552-0838-04",
"ProductNDC": "51552-0838",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tamoxifen Citrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "TAMOXIFEN CITRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-SEP-04",
"EndMarketingDatePackage": "30-SEP-24"
},
{
"NDCCode": "51552-0838-1",
"PackageDescription": "1 g in 1 CONTAINER (51552-0838-1)",
"NDC11Code": "51552-0838-01",
"ProductNDC": "51552-0838",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tamoxifen Citrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "TAMOXIFEN CITRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "51552-0838-2",
"PackageDescription": "5 g in 1 CONTAINER (51552-0838-2)",
"NDC11Code": "51552-0838-02",
"ProductNDC": "51552-0838",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tamoxifen Citrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "TAMOXIFEN CITRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "37662-0838-4",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-0838-4) ",
"NDC11Code": "37662-0838-04",
"ProductNDC": "37662-0838",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferrum Metallicum",
"NonProprietaryName": "Ferrum Metallicum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220712",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "IRON",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220712",
"SamplePackage": "N"
},
{
"NDCCode": "50090-0838-4",
"PackageDescription": "30 TABLET in 1 BOTTLE (50090-0838-4) ",
"NDC11Code": "50090-0838-04",
"ProductNDC": "50090-0838",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076471",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "52372-0838-4",
"PackageDescription": "1000 g in 1 CONTAINER (52372-0838-4)",
"NDC11Code": "52372-0838-04",
"ProductNDC": "52372-0838",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Hydrocortisone Acetate Micronized",
"DosageFormName": "POWDER",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Freedom Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10135-838-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-838-01) ",
"NDC11Code": "10135-0838-01",
"ProductNDC": "10135-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramelteon",
"NonProprietaryName": "Ramelteon",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215435",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "RAMELTEON",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Ramelteon Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)] .",
"Description": "Ramelteon is an orally active hypnotic chemically designated as (S-N-[2-(1,6,7,8-tetrahydro -2H-indeno-[5,4-b]furan-8-yl)ethyl] propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of. C 16H 21NO 2, molecular weight of 259.34, and the following chemical structure:. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon Tablet includes the following inactive ingredients: croscarmellose sodium, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, povidone, titanium dioxide, triacetin."
},
{
"NDCCode": "10135-838-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-838-30) ",
"NDC11Code": "10135-0838-30",
"ProductNDC": "10135-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramelteon",
"NonProprietaryName": "Ramelteon",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215435",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "RAMELTEON",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Ramelteon Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)] .",
"Description": "Ramelteon is an orally active hypnotic chemically designated as (S-N-[2-(1,6,7,8-tetrahydro -2H-indeno-[5,4-b]furan-8-yl)ethyl] propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of. C 16H 21NO 2, molecular weight of 259.34, and the following chemical structure:. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon Tablet includes the following inactive ingredients: croscarmellose sodium, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, povidone, titanium dioxide, triacetin."
},
{
"NDCCode": "10812-838-04",
"PackageDescription": "4.11 g in 1 CONTAINER (10812-838-04)",
"NDC11Code": "10812-0838-04",
"ProductNDC": "10812-838",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Nourishing Eye Quad",
"ProprietaryNameSuffix": "Spr 15 - Garden Party 160",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100329",
"EndMarketingDate": "20151201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Neutrogena Corporation",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "41.1",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "12634-838-00",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (12634-838-00)",
"NDC11Code": "12634-0838-00",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-50",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (12634-838-50)",
"NDC11Code": "12634-0838-50",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-54",
"PackageDescription": "14 CAPSULE in 1 BLISTER PACK (12634-838-54)",
"NDC11Code": "12634-0838-54",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-55",
"PackageDescription": "15 CAPSULE in 1 BLISTER PACK (12634-838-55)",
"NDC11Code": "12634-0838-55",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-57",
"PackageDescription": "20 CAPSULE in 1 BLISTER PACK (12634-838-57)",
"NDC11Code": "12634-0838-57",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-59",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (12634-838-59)",
"NDC11Code": "12634-0838-59",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (12634-838-60)",
"NDC11Code": "12634-0838-60",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-61",
"PackageDescription": "10 CAPSULE in 1 BLISTER PACK (12634-838-61)",
"NDC11Code": "12634-0838-61",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-66",
"PackageDescription": "6 CAPSULE in 1 BLISTER PACK (12634-838-66)",
"NDC11Code": "12634-0838-66",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-67",
"PackageDescription": "7 CAPSULE in 1 BLISTER PACK (12634-838-67)",
"NDC11Code": "12634-0838-67",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-71",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (12634-838-71)",
"NDC11Code": "12634-0838-71",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-79",
"PackageDescription": "25 CAPSULE in 1 BOTTLE (12634-838-79)",
"NDC11Code": "12634-0838-79",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-80",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (12634-838-80)",
"NDC11Code": "12634-0838-80",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-84",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (12634-838-84)",
"NDC11Code": "12634-0838-84",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-85",
"PackageDescription": "15 CAPSULE in 1 BOTTLE (12634-838-85)",
"NDC11Code": "12634-0838-85",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (12634-838-90)",
"NDC11Code": "12634-0838-90",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-91",
"PackageDescription": "1 CAPSULE in 1 BLISTER PACK (12634-838-91)",
"NDC11Code": "12634-0838-91",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-95",
"PackageDescription": "5 CAPSULE in 1 BOTTLE (12634-838-95)",
"NDC11Code": "12634-0838-95",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "12634-838-97",
"PackageDescription": "7 CAPSULE in 1 BOTTLE (12634-838-97)",
"NDC11Code": "12634-0838-97",
"ProductNDC": "12634-838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin Er",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074464",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "13537-838-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-838-02) > 4 g in 1 TUBE (13537-838-01)",
"NDC11Code": "13537-0838-02",
"ProductNDC": "13537-838",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25",
"ProprietaryNameSuffix": "(borgona Sexy Exotic) - Purple",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".0664; .0151",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-838-01",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (16714-838-01) ",
"NDC11Code": "16714-0838-01",
"ProductNDC": "16714-838",
"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": "80",
"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."
}
]
}
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<NDC>
<NDCCode>51552-0838-4</NDCCode>
<PackageDescription>100 g in 1 CONTAINER (51552-0838-4) </PackageDescription>
<NDC11Code>51552-0838-04</NDC11Code>
<ProductNDC>51552-0838</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tamoxifen Citrate</NonProprietaryName>
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<EndMarketingDate>20240930</EndMarketingDate>
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<SubstanceName>TAMOXIFEN CITRATE</SubstanceName>
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<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
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<EndMarketingDatePackage>30-SEP-24</EndMarketingDatePackage>
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<NDC>
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<PackageDescription>1 g in 1 CONTAINER (51552-0838-1)</PackageDescription>
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<StartMarketingDate>20040901</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>TAMOXIFEN CITRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51552-0838-2</NDCCode>
<PackageDescription>5 g in 1 CONTAINER (51552-0838-2)</PackageDescription>
<NDC11Code>51552-0838-02</NDC11Code>
<ProductNDC>51552-0838</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
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<SubstanceName>TAMOXIFEN CITRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>37662-0838-4</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-0838-4) </PackageDescription>
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<ProductNDC>37662-0838</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferrum Metallicum</ProprietaryName>
<NonProprietaryName>Ferrum Metallicum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
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<StartMarketingDate>20220712</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>IRON</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-0838-4</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (50090-0838-4) </PackageDescription>
<NDC11Code>50090-0838-04</NDC11Code>
<ProductNDC>50090-0838</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076471</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52372-0838-4</NDCCode>
<PackageDescription>1000 g in 1 CONTAINER (52372-0838-4)</PackageDescription>
<NDC11Code>52372-0838-04</NDC11Code>
<ProductNDC>52372-0838</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Hydrocortisone Acetate Micronized</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Freedom Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10135-838-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-838-01) </PackageDescription>
<NDC11Code>10135-0838-01</NDC11Code>
<ProductNDC>10135-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramelteon</ProprietaryName>
<NonProprietaryName>Ramelteon</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215435</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RAMELTEON</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramelteon Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Ramelteon is an orally active hypnotic chemically designated as (S-N-[2-(1,6,7,8-tetrahydro -2H-indeno-[5,4-b]furan-8-yl)ethyl] propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of. C 16H 21NO 2, molecular weight of 259.34, and the following chemical structure:. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon Tablet includes the following inactive ingredients: croscarmellose sodium, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, povidone, titanium dioxide, triacetin.</Description>
</NDC>
<NDC>
<NDCCode>10135-838-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-838-30) </PackageDescription>
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<ProductNDC>10135-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramelteon</ProprietaryName>
<NonProprietaryName>Ramelteon</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215435</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RAMELTEON</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramelteon Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Ramelteon is an orally active hypnotic chemically designated as (S-N-[2-(1,6,7,8-tetrahydro -2H-indeno-[5,4-b]furan-8-yl)ethyl] propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of. C 16H 21NO 2, molecular weight of 259.34, and the following chemical structure:. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon Tablet includes the following inactive ingredients: croscarmellose sodium, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, povidone, titanium dioxide, triacetin.</Description>
</NDC>
<NDC>
<NDCCode>10812-838-04</NDCCode>
<PackageDescription>4.11 g in 1 CONTAINER (10812-838-04)</PackageDescription>
<NDC11Code>10812-0838-04</NDC11Code>
<ProductNDC>10812-838</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Nourishing Eye Quad</ProprietaryName>
<ProprietaryNameSuffix>Spr 15 - Garden Party 160</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100329</StartMarketingDate>
<EndMarketingDate>20151201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Neutrogena Corporation</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>41.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>12634-838-00</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE (12634-838-00)</PackageDescription>
<NDC11Code>12634-0838-00</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-50</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (12634-838-50)</PackageDescription>
<NDC11Code>12634-0838-50</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-54</NDCCode>
<PackageDescription>14 CAPSULE in 1 BLISTER PACK (12634-838-54)</PackageDescription>
<NDC11Code>12634-0838-54</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-55</NDCCode>
<PackageDescription>15 CAPSULE in 1 BLISTER PACK (12634-838-55)</PackageDescription>
<NDC11Code>12634-0838-55</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-57</NDCCode>
<PackageDescription>20 CAPSULE in 1 BLISTER PACK (12634-838-57)</PackageDescription>
<NDC11Code>12634-0838-57</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-59</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (12634-838-59)</PackageDescription>
<NDC11Code>12634-0838-59</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (12634-838-60)</PackageDescription>
<NDC11Code>12634-0838-60</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-61</NDCCode>
<PackageDescription>10 CAPSULE in 1 BLISTER PACK (12634-838-61)</PackageDescription>
<NDC11Code>12634-0838-61</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-66</NDCCode>
<PackageDescription>6 CAPSULE in 1 BLISTER PACK (12634-838-66)</PackageDescription>
<NDC11Code>12634-0838-66</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-67</NDCCode>
<PackageDescription>7 CAPSULE in 1 BLISTER PACK (12634-838-67)</PackageDescription>
<NDC11Code>12634-0838-67</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-71</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (12634-838-71)</PackageDescription>
<NDC11Code>12634-0838-71</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-79</NDCCode>
<PackageDescription>25 CAPSULE in 1 BOTTLE (12634-838-79)</PackageDescription>
<NDC11Code>12634-0838-79</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-80</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (12634-838-80)</PackageDescription>
<NDC11Code>12634-0838-80</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-84</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (12634-838-84)</PackageDescription>
<NDC11Code>12634-0838-84</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-85</NDCCode>
<PackageDescription>15 CAPSULE in 1 BOTTLE (12634-838-85)</PackageDescription>
<NDC11Code>12634-0838-85</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (12634-838-90)</PackageDescription>
<NDC11Code>12634-0838-90</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-91</NDCCode>
<PackageDescription>1 CAPSULE in 1 BLISTER PACK (12634-838-91)</PackageDescription>
<NDC11Code>12634-0838-91</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-95</NDCCode>
<PackageDescription>5 CAPSULE in 1 BOTTLE (12634-838-95)</PackageDescription>
<NDC11Code>12634-0838-95</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>12634-838-97</NDCCode>
<PackageDescription>7 CAPSULE in 1 BOTTLE (12634-838-97)</PackageDescription>
<NDC11Code>12634-0838-97</NDC11Code>
<ProductNDC>12634-838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin Er</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074464</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease. , 2 Moderate to severe ankylosing spondylitis. , 3 Moderate to severe osteoarthritis. , 4 Acute painful shoulder (bursitis and/or tendinitis). , 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP for oral administration are provided in one dosage strengths which contain 75 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Manufacture KVK-Tech. Inc. Each extended release capsule contains 75 mg of Indomethacin. In addition each capsule contains the following inactive ingredients:corn starch, D and C yellow #10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. Manufacture Sandoz, Inc.Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D and C yellow No. 10, D and C yellow No. 10 aluminum lake, FD and C blue No. 1 aluminum lake, FD and C blue No. 2 aluminum lake, FD and C red No. 40 aluminum lake, FD and C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide.This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>13537-838-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-838-02) > 4 g in 1 TUBE (13537-838-01)</PackageDescription>
<NDC11Code>13537-0838-02</NDC11Code>
<ProductNDC>13537-838</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(borgona Sexy Exotic) - Purple</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.0664; .0151</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-838-01</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (16714-838-01) </PackageDescription>
<NDC11Code>16714-0838-01</NDC11Code>
<ProductNDC>16714-838</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>80</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>
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