{
"NDC": [
{
"NDCCode": "50090-0838-3",
"PackageDescription": "15 TABLET in 1 BOTTLE (50090-0838-3) ",
"NDC11Code": "50090-0838-03",
"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": "37662-0838-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-0838-3) ",
"NDC11Code": "37662-0838-03",
"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": "49288-0838-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0838-3)",
"NDC11Code": "49288-0838-03",
"ProductNDC": "49288-0838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Treatment Set Ts344592",
"NonProprietaryName": "Treatment Set Ts344592",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19861031",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS; CANIS LUPUS FAMILIARIS HAIR",
"StrengthNumber": "2000; .002",
"StrengthUnit": "[AU]/mL; g/mL",
"Pharm_Classes": "Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Animal Fur [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11. THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.",
"Description": "Allergenic extract in this vial is referred to as an individual treatment vial since it is designed primarily for the physician equipped to complete skin testing and supervise allergenic extract immunotherapy. The extract is sterile and intended for subcutaneous injection. The concentration of allergenic extract supplied will be based on the individual physician's prescription order and will be expressed in most cases on a weight/volume basis (or AU/ml with standardized extract) diluted either 1:10 or 1:5. Where mixtures of pollens and non-pollens have been ordered, the ingredients are listed on the final container label. To insure maximum potency for the entire dating period, dilutions will be prepared with 50% v/v glycerine unless otherwise specified. Ingredients - Active allergens, preservative and stabilizer are noted on the Physicians Prescription Ingredients Insert enclosed with each individual allergenic extract treatment vial. Dating Period - A twelve month dating period (expiration date) for the prescription vial will be on the container label. Extract Treatment Sets should be reordered when outdated. Government requirements include a two week holding period for sterility tests. Please allow three weeks minimum for delivery."
},
{
"NDCCode": "52372-0838-3",
"PackageDescription": "100 g in 1 CONTAINER (52372-0838-3)",
"NDC11Code": "52372-0838-03",
"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": "67046-0838-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-0838-3) ",
"NDC11Code": "67046-0838-03",
"ProductNDC": "67046-0838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077580",
"LabelerName": "Coupler LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260429",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol is indicated for use in the management of manifestations of psychotic disorders. Haloperidol is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol is also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-( p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone. It has the following structural formula. Each haloperidol tablet, USP intended for oral administration contains haloperidol, USP 0.5 mg or 1 mg or 2 mg or 5 mg or 10 mg or 20 mg. In addition each 0.5 mg, 1 mg, 2 mg tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize) and each 5 mg, 10 mg, 20 mg tablet contains the following inactive ingredients: calcium stearate, dibasic calcium phosphate dihydrate, povidone (PVP K 30), sodium starch glycolate and starch. 1 mg:D&C Yellow #10 Aluminium Lake, FD&C Yellow #6 Aluminium Lake; 2 mg:D & C Red #27 Aluminum Lake; 5 mg:D & C Yellow #10 Aluminum Lake and FD & C Blue #1 Aluminum Lake; 10 mg:D & C Yellow #10 Aluminum Lake and FD & C Blue #1 Aluminum Lake; 20 mg:FD & C Yellow #6 Aluminum Lake and D & C Red #27 Aluminum Lake."
},
{
"NDCCode": "71335-0838-3",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-0838-3) ",
"NDC11Code": "71335-0838-03",
"ProductNDC": "71335-0838",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19551231",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA010187",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2021-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100226",
"SamplePackage": "N"
},
{
"NDCCode": "50090-0838-0",
"PackageDescription": "10 TABLET in 1 BOTTLE (50090-0838-0) ",
"NDC11Code": "50090-0838-00",
"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": "50090-0838-1",
"PackageDescription": "20 TABLET in 1 BOTTLE (50090-0838-1) ",
"NDC11Code": "50090-0838-01",
"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": "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": "50090-0838-5",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-0838-5) ",
"NDC11Code": "50090-0838-05",
"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": "50090-0838-6",
"PackageDescription": "7 TABLET in 1 BOTTLE (50090-0838-6) ",
"NDC11Code": "50090-0838-06",
"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": "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": "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."
}
]
}
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<NDCList>
<NDC>
<NDCCode>50090-0838-3</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (50090-0838-3) </PackageDescription>
<NDC11Code>50090-0838-03</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>37662-0838-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-0838-3) </PackageDescription>
<NDC11Code>37662-0838-03</NDC11Code>
<ProductNDC>37662-0838</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferrum Metallicum</ProprietaryName>
<NonProprietaryName>Ferrum Metallicum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<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>49288-0838-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0838-3)</PackageDescription>
<NDC11Code>49288-0838-03</NDC11Code>
<ProductNDC>49288-0838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Treatment Set Ts344592</ProprietaryName>
<NonProprietaryName>Treatment Set Ts344592</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19861031</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES PTERONYSSINUS; CANIS LUPUS FAMILIARIS HAIR</SubstanceName>
<StrengthNumber>2000; .002</StrengthNumber>
<StrengthUnit>[AU]/mL; g/mL</StrengthUnit>
<Pharm_Classes>Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Animal Fur [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11. THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.</IndicationAndUsage>
<Description>Allergenic extract in this vial is referred to as an individual treatment vial since it is designed primarily for the physician equipped to complete skin testing and supervise allergenic extract immunotherapy. The extract is sterile and intended for subcutaneous injection. The concentration of allergenic extract supplied will be based on the individual physician's prescription order and will be expressed in most cases on a weight/volume basis (or AU/ml with standardized extract) diluted either 1:10 or 1:5. Where mixtures of pollens and non-pollens have been ordered, the ingredients are listed on the final container label. To insure maximum potency for the entire dating period, dilutions will be prepared with 50% v/v glycerine unless otherwise specified. Ingredients - Active allergens, preservative and stabilizer are noted on the Physicians Prescription Ingredients Insert enclosed with each individual allergenic extract treatment vial. Dating Period - A twelve month dating period (expiration date) for the prescription vial will be on the container label. Extract Treatment Sets should be reordered when outdated. Government requirements include a two week holding period for sterility tests. Please allow three weeks minimum for delivery.</Description>
</NDC>
<NDC>
<NDCCode>52372-0838-3</NDCCode>
<PackageDescription>100 g in 1 CONTAINER (52372-0838-3)</PackageDescription>
<NDC11Code>52372-0838-03</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>67046-0838-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-0838-3) </PackageDescription>
<NDC11Code>67046-0838-03</NDC11Code>
<ProductNDC>67046-0838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077580</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol is indicated for use in the management of manifestations of psychotic disorders. Haloperidol is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol is also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-( p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone. It has the following structural formula. Each haloperidol tablet, USP intended for oral administration contains haloperidol, USP 0.5 mg or 1 mg or 2 mg or 5 mg or 10 mg or 20 mg. In addition each 0.5 mg, 1 mg, 2 mg tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize) and each 5 mg, 10 mg, 20 mg tablet contains the following inactive ingredients: calcium stearate, dibasic calcium phosphate dihydrate, povidone (PVP K 30), sodium starch glycolate and starch. 1 mg:D&C Yellow #10 Aluminium Lake, FD&C Yellow #6 Aluminium Lake; 2 mg:D & C Red #27 Aluminum Lake; 5 mg:D & C Yellow #10 Aluminum Lake and FD & C Blue #1 Aluminum Lake; 10 mg:D & C Yellow #10 Aluminum Lake and FD & C Blue #1 Aluminum Lake; 20 mg:FD & C Yellow #6 Aluminum Lake and D & C Red #27 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>71335-0838-3</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71335-0838-3) </PackageDescription>
<NDC11Code>71335-0838-03</NDC11Code>
<ProductNDC>71335-0838</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19551231</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA010187</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-0838-0</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (50090-0838-0) </PackageDescription>
<NDC11Code>50090-0838-00</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>50090-0838-1</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (50090-0838-1) </PackageDescription>
<NDC11Code>50090-0838-01</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>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>50090-0838-5</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-0838-5) </PackageDescription>
<NDC11Code>50090-0838-05</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>50090-0838-6</NDCCode>
<PackageDescription>7 TABLET in 1 BOTTLE (50090-0838-6) </PackageDescription>
<NDC11Code>50090-0838-06</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>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>
<NDC11Code>10135-0838-30</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>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>
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