{
"NDC": [
{
"NDCCode": "55111-146-78",
"PackageDescription": "10 DOSE PACK in 1 CARTON (55111-146-78) / 10 TABLET in 1 DOSE PACK (55111-146-79) ",
"NDC11Code": "55111-0146-78",
"ProductNDC": "55111-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076658",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2."
},
{
"NDCCode": "53247-146-05",
"PackageDescription": "78 g in 1 TUBE (53247-146-05) ",
"NDC11Code": "53247-0146-05",
"ProductNDC": "53247-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meridian Anticavity Fluoride",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20260914",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Bob Barker Company Inc.",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": "7.6",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260914",
"SamplePackage": "N",
"IndicationAndUsage": "Helps protect against cavities."
},
{
"NDCCode": "63187-146-78",
"PackageDescription": "180 TABLET in 1 BOTTLE (63187-146-78) ",
"NDC11Code": "63187-0146-78",
"ProductNDC": "63187-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077836",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20140801",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil Tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease (ref. 6). Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID BNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.",
"Description": "Gemfibrozil is a lipid regulating agent. Gemfibrozil Tablets USP for oral administration, contain 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, NF; croscarmellose sodium, NF; calcium stearate, NF; microcrystalline cellulose, NF; methylcellulose, USP and opadry white. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H2203 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°- 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "55111-146-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (55111-146-01) ",
"NDC11Code": "55111-0146-01",
"ProductNDC": "55111-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076658",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-146-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-146-05) ",
"NDC11Code": "55111-0146-05",
"ProductNDC": "55111-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076658",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-146-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (55111-146-30) ",
"NDC11Code": "55111-0146-30",
"ProductNDC": "55111-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076658",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-113-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-113-78) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79) ",
"NDC11Code": "55111-0113-78",
"ProductNDC": "55111-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zenatane",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202099",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150309",
"SamplePackage": "N",
"IndicationAndUsage": "Zenatane is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Zenatane is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of Zenatane treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. Isotretinoin has high lipophilicity. The structural formula is. Zenatane (isotretinoin capsules, USP) contains 10 mg, 20 mg, 30 mg, or 40 mg of isotretinoin (a retinoid) for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferric oxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue (LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Meets USP Dissolution Test 5."
},
{
"NDCCode": "55111-126-78",
"PackageDescription": "10 DOSE PACK in 1 BOX (55111-126-78) / 10 TABLET, FILM COATED in 1 DOSE PACK (55111-126-79) ",
"NDC11Code": "55111-0126-78",
"ProductNDC": "55111-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075593",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20040609",
"SamplePackage": "N",
"Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-127-78",
"PackageDescription": "10 DOSE PACK in 1 BOX (55111-127-78) / 10 TABLET, FILM COATED in 1 DOSE PACK (55111-127-79) ",
"NDC11Code": "55111-0127-78",
"ProductNDC": "55111-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075593",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20040609",
"SamplePackage": "N",
"Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-128-78",
"PackageDescription": "10 DOSE PACK in 1 BOX (55111-128-78) / 10 TABLET, FILM COATED in 1 DOSE PACK (55111-128-79) ",
"NDC11Code": "55111-0128-78",
"ProductNDC": "55111-128",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075593",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20040609",
"SamplePackage": "N",
"Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-143-78",
"PackageDescription": "10 DOSE PACK in 1 CARTON (55111-143-78) / 10 TABLET in 1 DOSE PACK (55111-143-79) ",
"NDC11Code": "55111-0143-78",
"ProductNDC": "55111-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076658",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-144-78",
"PackageDescription": "10 DOSE PACK in 1 CARTON (55111-144-78) / 10 TABLET in 1 DOSE PACK (55111-144-79) ",
"NDC11Code": "55111-0144-78",
"ProductNDC": "55111-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076658",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-150-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-150-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-150-79) ",
"NDC11Code": "55111-0150-78",
"ProductNDC": "55111-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076006",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160930",
"SamplePackage": "N",
"Description": "Fluoxetine tablets USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride USP is a white to off-white crystalline powder, sparingly soluble in water and in dichloromethane; freely soluble in methanol, and in alcohol, practically insoluble in ether. Each tablet contains fluoxetine hydrochloride USP equivalent to 10 mg (32.3 µmol) and 20 mg (64.7 µmol) of fluoxetine. The tablet also contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. In addition, the coating for each tablet contains FD&C Blue #1 (10 mg), hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "55111-153-78",
"PackageDescription": "10 DOSE PACK in 1 BOX (55111-153-78) / 10 TABLET, FILM COATED in 1 DOSE PACK",
"NDC11Code": "55111-0153-78",
"ProductNDC": "55111-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076183",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061226",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-154-78",
"PackageDescription": "10 DOSE PACK in 1 BOX (55111-154-78) / 10 TABLET, FILM COATED in 1 DOSE PACK (55111-154-79) ",
"NDC11Code": "55111-0154-78",
"ProductNDC": "55111-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076183",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061226",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-155-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-155-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-155-79) ",
"NDC11Code": "55111-0155-78",
"ProductNDC": "55111-155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076183",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061226",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate USP is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-156-78",
"PackageDescription": "10 DOSE PACK in 1 BOX (55111-156-78) / 10 TABLET, FILM COATED in 1 DOSE PACK (55111-156-79) ",
"NDC11Code": "55111-0156-78",
"ProductNDC": "55111-156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076183",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "24",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061226",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-157-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-157-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-157-79) ",
"NDC11Code": "55111-0157-78",
"ProductNDC": "55111-157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075576",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090121",
"SamplePackage": "N",
"Description": "The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-158-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-158-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-158-79) ",
"NDC11Code": "55111-0158-78",
"ProductNDC": "55111-158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075576",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090121",
"SamplePackage": "N",
"Description": "The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-159-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-159-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-159-79) ",
"NDC11Code": "55111-0159-78",
"ProductNDC": "55111-159",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075576",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20271231",
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"Description": "The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-160-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-160-78) > 10 TABLET, COATED in 1 BLISTER PACK (55111-160-79) ",
"NDC11Code": "55111-0160-78",
"ProductNDC": "55111-160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077098",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-03-23",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20060210",
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"NDCCode": "55111-161-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-161-78) > 10 TABLET, COATED in 1 BLISTER PACK (55111-161-79) ",
"NDC11Code": "55111-0161-78",
"ProductNDC": "55111-161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077098",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20060210",
"SamplePackage": "N"
},
{
"NDCCode": "55111-162-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-162-78) > 10 TABLET, COATED in 1 BLISTER PACK (55111-162-79) ",
"NDC11Code": "55111-0162-78",
"ProductNDC": "55111-162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077098",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20060210",
"SamplePackage": "N"
},
{
"NDCCode": "55111-163-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-163-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-163-79) ",
"NDC11Code": "55111-0163-78",
"ProductNDC": "55111-163",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Ltd.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120423",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide."
},
{
"NDCCode": "55111-164-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-164-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-164-79)",
"NDC11Code": "55111-0164-78",
"ProductNDC": "55111-164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120423",
"EndMarketingDate": "20150930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr.Reddy's laboratories Ltd.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "55111-165-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-165-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-165-79)",
"NDC11Code": "55111-0165-78",
"ProductNDC": "55111-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120423",
"EndMarketingDate": "20150930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr.Reddy's laboratories Ltd.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "55111-166-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-166-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-166-79)",
"NDC11Code": "55111-0166-78",
"ProductNDC": "55111-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120423",
"EndMarketingDate": "20150930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr.Reddy's laboratories Ltd.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "55111-167-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-167-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-167-79) ",
"NDC11Code": "55111-0167-78",
"ProductNDC": "55111-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076133",
"LabelerName": "Dr. Reddy's Laboratories Ltd.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120423",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 15 mg (48 μmol) and 20 mg (64 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "55111-168-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-168-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-168-79) ",
"NDC11Code": "55111-0168-78",
"ProductNDC": "55111-168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076133",
"LabelerName": "Dr. Reddy's Laboratories Ltd.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120423",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 15 mg (48 μmol) and 20 mg (64 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "55111-169-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-169-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-169-79) ",
"NDC11Code": "55111-0169-78",
"ProductNDC": "55111-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077380",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120327",
"SamplePackage": "N",
"Description": "Quetiapine fumarate is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder soluble in DMF, slightly soluble in methanol. Quetiapine fumarare tablets are supplied for oral administration as 25 mg (round, white), 50 mg (round, white), 100 mg (round, yellow), 150 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dehydrate (fine powder), lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate. The 25 mg, 50 mg, 200 mg and 300 mg tablets contain opadry white OY58900 (hypromellose 5 cp, polyethylene glycol 400, titanium dioxide) and 100 mg, 150 mg and 400 mg tablets contains opadry yellow OY52945 (hypromellose 5 cp, iron oxide yellow, polyethylene glycol 400, titanium dioxide)."
}
]
}
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<NDCList>
<NDC>
<NDCCode>55111-146-78</NDCCode>
<PackageDescription>10 DOSE PACK in 1 CARTON (55111-146-78) / 10 TABLET in 1 DOSE PACK (55111-146-79) </PackageDescription>
<NDC11Code>55111-0146-78</NDC11Code>
<ProductNDC>55111-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076658</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
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<Status>Active</Status>
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<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2.</Description>
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<ProductNDC>53247-146</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Meridian Anticavity Fluoride</ProprietaryName>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20260914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Bob Barker Company Inc.</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>7.6</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps protect against cavities.</IndicationAndUsage>
</NDC>
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<NDCCode>63187-146-78</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (63187-146-78) </PackageDescription>
<NDC11Code>63187-0146-78</NDC11Code>
<ProductNDC>63187-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077836</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil Tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease (ref. 6). Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID BNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
<Description>Gemfibrozil is a lipid regulating agent. Gemfibrozil Tablets USP for oral administration, contain 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, NF; croscarmellose sodium, NF; calcium stearate, NF; microcrystalline cellulose, NF; methylcellulose, USP and opadry white. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H2203 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°- 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
</NDC>
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<NDCCode>55111-146-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (55111-146-01) </PackageDescription>
<NDC11Code>55111-0146-01</NDC11Code>
<ProductNDC>55111-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076658</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-146-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-146-05) </PackageDescription>
<NDC11Code>55111-0146-05</NDC11Code>
<ProductNDC>55111-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076658</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2.</Description>
</NDC>
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<NDCCode>55111-146-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (55111-146-30) </PackageDescription>
<NDC11Code>55111-0146-30</NDC11Code>
<ProductNDC>55111-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076658</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-113-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-113-78) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79) </PackageDescription>
<NDC11Code>55111-0113-78</NDC11Code>
<ProductNDC>55111-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zenatane</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202099</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zenatane is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Zenatane is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of Zenatane treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. Isotretinoin has high lipophilicity. The structural formula is. Zenatane (isotretinoin capsules, USP) contains 10 mg, 20 mg, 30 mg, or 40 mg of isotretinoin (a retinoid) for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferric oxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue (LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>55111-126-78</NDCCode>
<PackageDescription>10 DOSE PACK in 1 BOX (55111-126-78) / 10 TABLET, FILM COATED in 1 DOSE PACK (55111-126-79) </PackageDescription>
<NDC11Code>55111-0126-78</NDC11Code>
<ProductNDC>55111-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075593</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-127-78</NDCCode>
<PackageDescription>10 DOSE PACK in 1 BOX (55111-127-78) / 10 TABLET, FILM COATED in 1 DOSE PACK (55111-127-79) </PackageDescription>
<NDC11Code>55111-0127-78</NDC11Code>
<ProductNDC>55111-127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075593</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-128-78</NDCCode>
<PackageDescription>10 DOSE PACK in 1 BOX (55111-128-78) / 10 TABLET, FILM COATED in 1 DOSE PACK (55111-128-79) </PackageDescription>
<NDC11Code>55111-0128-78</NDC11Code>
<ProductNDC>55111-128</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075593</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-143-78</NDCCode>
<PackageDescription>10 DOSE PACK in 1 CARTON (55111-143-78) / 10 TABLET in 1 DOSE PACK (55111-143-79) </PackageDescription>
<NDC11Code>55111-0143-78</NDC11Code>
<ProductNDC>55111-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076658</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2.</Description>
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<NDCCode>55111-144-78</NDCCode>
<PackageDescription>10 DOSE PACK in 1 CARTON (55111-144-78) / 10 TABLET in 1 DOSE PACK (55111-144-79) </PackageDescription>
<NDC11Code>55111-0144-78</NDC11Code>
<ProductNDC>55111-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076658</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2.</Description>
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<NDCCode>55111-150-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-150-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-150-79) </PackageDescription>
<NDC11Code>55111-0150-78</NDC11Code>
<ProductNDC>55111-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076006</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Fluoxetine tablets USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride USP is a white to off-white crystalline powder, sparingly soluble in water and in dichloromethane; freely soluble in methanol, and in alcohol, practically insoluble in ether. Each tablet contains fluoxetine hydrochloride USP equivalent to 10 mg (32.3 µmol) and 20 mg (64.7 µmol) of fluoxetine. The tablet also contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. In addition, the coating for each tablet contains FD&C Blue #1 (10 mg), hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-153-78</NDCCode>
<PackageDescription>10 DOSE PACK in 1 BOX (55111-153-78) / 10 TABLET, FILM COATED in 1 DOSE PACK</PackageDescription>
<NDC11Code>55111-0153-78</NDC11Code>
<ProductNDC>55111-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076183</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
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<NDCCode>55111-154-78</NDCCode>
<PackageDescription>10 DOSE PACK in 1 BOX (55111-154-78) / 10 TABLET, FILM COATED in 1 DOSE PACK (55111-154-79) </PackageDescription>
<NDC11Code>55111-0154-78</NDC11Code>
<ProductNDC>55111-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076183</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
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<NDC>
<NDCCode>55111-155-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-155-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-155-79) </PackageDescription>
<NDC11Code>55111-0155-78</NDC11Code>
<ProductNDC>55111-155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076183</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate USP is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-156-78</NDCCode>
<PackageDescription>10 DOSE PACK in 1 BOX (55111-156-78) / 10 TABLET, FILM COATED in 1 DOSE PACK (55111-156-79) </PackageDescription>
<NDC11Code>55111-0156-78</NDC11Code>
<ProductNDC>55111-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076183</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>24</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-157-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-157-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-157-79) </PackageDescription>
<NDC11Code>55111-0157-78</NDC11Code>
<ProductNDC>55111-157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075576</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-158-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-158-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-158-79) </PackageDescription>
<NDC11Code>55111-0158-78</NDC11Code>
<ProductNDC>55111-158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075576</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-159-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-159-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-159-79) </PackageDescription>
<NDC11Code>55111-0159-78</NDC11Code>
<ProductNDC>55111-159</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075576</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-160-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-160-78) > 10 TABLET, COATED in 1 BLISTER PACK (55111-160-79) </PackageDescription>
<NDC11Code>55111-0160-78</NDC11Code>
<ProductNDC>55111-160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077098</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55111-161-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-161-78) > 10 TABLET, COATED in 1 BLISTER PACK (55111-161-79) </PackageDescription>
<NDC11Code>55111-0161-78</NDC11Code>
<ProductNDC>55111-161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077098</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55111-162-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-162-78) > 10 TABLET, COATED in 1 BLISTER PACK (55111-162-79) </PackageDescription>
<NDC11Code>55111-0162-78</NDC11Code>
<ProductNDC>55111-162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077098</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55111-163-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-163-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-163-79) </PackageDescription>
<NDC11Code>55111-0163-78</NDC11Code>
<ProductNDC>55111-163</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Ltd.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-164-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-164-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-164-79)</PackageDescription>
<NDC11Code>55111-0164-78</NDC11Code>
<ProductNDC>55111-164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120423</StartMarketingDate>
<EndMarketingDate>20150930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr.Reddy's laboratories Ltd.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>55111-165-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-165-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-165-79)</PackageDescription>
<NDC11Code>55111-0165-78</NDC11Code>
<ProductNDC>55111-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120423</StartMarketingDate>
<EndMarketingDate>20150930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr.Reddy's laboratories Ltd.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>55111-166-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-166-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-166-79)</PackageDescription>
<NDC11Code>55111-0166-78</NDC11Code>
<ProductNDC>55111-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120423</StartMarketingDate>
<EndMarketingDate>20150930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr.Reddy's laboratories Ltd.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>55111-167-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-167-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-167-79) </PackageDescription>
<NDC11Code>55111-0167-78</NDC11Code>
<ProductNDC>55111-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076133</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Ltd.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 15 mg (48 μmol) and 20 mg (64 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-168-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-168-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-168-79) </PackageDescription>
<NDC11Code>55111-0168-78</NDC11Code>
<ProductNDC>55111-168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076133</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Ltd.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 15 mg (48 μmol) and 20 mg (64 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-169-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-169-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-169-79) </PackageDescription>
<NDC11Code>55111-0169-78</NDC11Code>
<ProductNDC>55111-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077380</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Quetiapine fumarate is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder soluble in DMF, slightly soluble in methanol. Quetiapine fumarare tablets are supplied for oral administration as 25 mg (round, white), 50 mg (round, white), 100 mg (round, yellow), 150 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dehydrate (fine powder), lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate. The 25 mg, 50 mg, 200 mg and 300 mg tablets contain opadry white OY58900 (hypromellose 5 cp, polyethylene glycol 400, titanium dioxide) and 100 mg, 150 mg and 400 mg tablets contains opadry yellow OY52945 (hypromellose 5 cp, iron oxide yellow, polyethylene glycol 400, titanium dioxide).</Description>
</NDC>
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