{
"NDC": [
{
"NDCCode": "50090-1820-0",
"PackageDescription": "1 KIT in 1 KIT (50090-1820-0) * 1 mL in 1 VIAL, GLASS (63851-511-11) * 1 mL in 1 SYRINGE (63851-512-12) ",
"NDC11Code": "50090-1820-00",
"ProductNDC": "50090-1820",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Rabavert",
"NonProprietaryName": "Rabies Vaccine",
"DosageFormName": "KIT",
"StartMarketingDate": "20140708",
"EndMarketingDate": "20200331",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103334",
"LabelerName": "A-S Medication Solutions",
"Status": "Deprecated",
"LastUpdate": "2020-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140708",
"EndMarketingDatePackage": "20200331",
"SamplePackage": "N"
},
{
"NDCCode": "70518-1820-0",
"PackageDescription": "30 POUCH in 1 BOX, UNIT-DOSE (70518-1820-0) > 1 TABLET in 1 POUCH (70518-1820-1) ",
"NDC11Code": "70518-1820-00",
"ProductNDC": "70518-1820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076008",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190124",
"SamplePackage": "N"
},
{
"NDCCode": "77768-1820-0",
"PackageDescription": "3875 mL in 1 JUG (77768-1820-0) ",
"NDC11Code": "77768-1820-00",
"ProductNDC": "77768-1820",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clean Up By Katom Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200322",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "KaTom Restaurant Supply, INC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "68071-1820-2",
"PackageDescription": "200 mL in 1 BOTTLE (68071-1820-2) ",
"NDC11Code": "68071-1820-02",
"ProductNDC": "68071-1820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060456",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170731",
"SamplePackage": "N",
"IndicationAndUsage": "Penicillin V potassium tablets and penicillin V potassium for oral solution are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal infections (without bacteremia). Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant. Pneumococcal infections. Mild to moderately severe infections of the respiratory tract. Staphylococcal infections—penicillin G-sensitive. Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis)—Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium tablets, penicillin V potassium for oral solution, and other antibacterial drugs, penicillin V potassium tablets and penicillin V potassium for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Each penicillin V potassium tablet, USP contains penicillin V potassium equivalent to 250 mg (400,000 units) or 500 mg (800,000 units) penicillin V. The inactive ingredients present are dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Each penicillin V potassium tablet, USP, 250 mg contains 0.71 mEq (27.9 mg) of potassium and each penicillin V potassium tablet, USP, 500 mg contains 1.43 mEq (55.8 mg) of potassium. Penicillin V potassium for oral solution, USP is an off-white to pinkish colored powder, which when reconstituted as directed, yields a red colored solution with cherry flavor in which each 5 mL contains penicillin V potassium equivalent to 125 mg (200,000 units) or 250 mg (400,000 units) penicillin V. The inactive ingredients present are cherry flavor, FD&C Red #40, saccharin sodium, sodium benzoate, and sugar. Each 5 mL of reconstituted penicillin V potassium for oral solution, USP, 125 mg (200,000 units) per 5 mL contains 0.36 mEq (13.9 mg) of potassium. Each 5 mL of reconstituted penicillin V potassium for oral solution, USP, 250 mg (400,000 units) per 5 mL contains 0.71 mEq (27.9 mg) of potassium. Monopotassium (2 S,5 R,6 R)-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate."
},
{
"NDCCode": "71335-1820-1",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-1) ",
"NDC11Code": "71335-1820-01",
"ProductNDC": "71335-1820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203203",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210505",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).",
"Description": "The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac."
},
{
"NDCCode": "71335-1820-2",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-2) ",
"NDC11Code": "71335-1820-02",
"ProductNDC": "71335-1820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203203",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210521",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).",
"Description": "The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac."
},
{
"NDCCode": "71335-1820-3",
"PackageDescription": "18 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-3) ",
"NDC11Code": "71335-1820-03",
"ProductNDC": "71335-1820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203203",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220706",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).",
"Description": "The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac."
},
{
"NDCCode": "71335-1820-4",
"PackageDescription": "28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-4) ",
"NDC11Code": "71335-1820-04",
"ProductNDC": "71335-1820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203203",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220706",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).",
"Description": "The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac."
},
{
"NDCCode": "71335-1820-5",
"PackageDescription": "56 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-5) ",
"NDC11Code": "71335-1820-05",
"ProductNDC": "71335-1820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203203",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220706",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).",
"Description": "The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac."
},
{
"NDCCode": "71335-1820-6",
"PackageDescription": "58 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-6) ",
"NDC11Code": "71335-1820-06",
"ProductNDC": "71335-1820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203203",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220706",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).",
"Description": "The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203203",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-15",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20220706",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).",
"Description": "The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac."
},
{
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203203",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20220706",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).",
"Description": "The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac."
},
{
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"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203203",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
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"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).",
"Description": "The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac."
},
{
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"ProductTypeName": "HUMAN OTC DRUG",
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"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily : 1 reduces fever , 2 relieves minor aches, pains, and headache."
},
{
"NDCCode": "50090-0002-0",
"PackageDescription": "1000 TABLET in 1 BOTTLE (50090-0002-0) ",
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"ProductNDC": "50090-0002",
"ProductTypeName": "HUMAN OTC DRUG",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181023",
"SamplePackage": "N"
},
{
"NDCCode": "50090-0004-0",
"PackageDescription": "15 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0004-0) ",
"NDC11Code": "50090-0004-00",
"ProductNDC": "50090-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pharbest Aspirin 325mg",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100920",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20141201",
"SamplePackage": "N"
},
{
"NDCCode": "50090-0005-0",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50090-0005-0) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50090-0005-00",
"ProductNDC": "50090-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19840819",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ACETAMINOPHEN",
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"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: the common coldheadachebackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "50090-0007-0",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (50090-0007-0)",
"NDC11Code": "50090-0007-00",
"ProductNDC": "50090-0007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089805",
"LabelerName": "A-S Medication Solutions LLC",
"SubstanceName": "CODEINE PHOSPHATE; ACETAMINOPHEN",
"StrengthNumber": "30; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "50090-0009-0",
"PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (50090-0009-0)",
"NDC11Code": "50090-0009-00",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089805",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CODEINE PHOSPHATE; ACETAMINOPHEN",
"StrengthNumber": "30; 300",
"StrengthUnit": "mg/1; mg/1",
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"Status": "Deprecated",
"LastUpdate": "2017-06-08"
},
{
"NDCCode": "50090-0010-0",
"PackageDescription": "10 TABLET in 1 BOTTLE (50090-0010-0)",
"NDC11Code": "50090-0010-00",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078060",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-13"
},
{
"NDCCode": "50090-0011-0",
"PackageDescription": "40 TABLET in 1 BOTTLE (50090-0011-0)",
"NDC11Code": "50090-0011-00",
"ProductNDC": "50090-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078060",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "50090-0015-0",
"PackageDescription": "10 TABLET in 1 BOTTLE (50090-0015-0)",
"NDC11Code": "50090-0015-00",
"ProductNDC": "50090-0015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-10-11",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "50090-0016-0",
"PackageDescription": "40 TABLET in 1 BOTTLE (50090-0016-0)",
"NDC11Code": "50090-0016-00",
"ProductNDC": "50090-0016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "A-S Medication Solutions LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50090-0017-0",
"PackageDescription": "20 TABLET in 1 BOTTLE (50090-0017-0)",
"NDC11Code": "50090-0017-00",
"ProductNDC": "50090-0017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "A-S Medication Solutions LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50090-0018-0",
"PackageDescription": "6 TABLET in 1 BOTTLE (50090-0018-0)",
"NDC11Code": "50090-0018-00",
"ProductNDC": "50090-0018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "A-S Medication Solutions LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50090-0019-0",
"PackageDescription": "6 TABLET in 1 BOTTLE (50090-0019-0)",
"NDC11Code": "50090-0019-00",
"ProductNDC": "50090-0019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-01-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "50090-0020-0",
"PackageDescription": "16 CAPSULE in 1 BOTTLE (50090-0020-0) ",
"NDC11Code": "50090-0020-00",
"ProductNDC": "50090-0020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amantadine Hydrochloride",
"NonProprietaryName": "Amantadine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071293",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181002",
"SamplePackage": "N",
"IndicationAndUsage": "Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.",
"Description": "Amantadine hydrochloride, USP is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride, USP has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride, USP is available as 100 mg capsules for oral administration. Inactive ingredients: corn starch, croscarmellose sodium, ethylcellulose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The capsule shells and imprinting ink contain: ammonium hydroxide,FD&C Blue #1, FD&C Red #40, gelatin, methylparaben, propylene glycol, propylparaben, shellac, simethicone, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "50090-0021-0",
"PackageDescription": "10 TABLET, COATED in 1 BOTTLE (50090-0021-0)",
"NDC11Code": "50090-0021-00",
"ProductNDC": "50090-0021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "A-S Medication Solutions LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50090-0022-0",
"PackageDescription": "6 TABLET, COATED in 1 BOTTLE (50090-0022-0) ",
"NDC11Code": "50090-0022-00",
"ProductNDC": "50090-0022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-10-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N"
},
{
"NDCCode": "50090-0023-0",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-0023-0) ",
"NDC11Code": "50090-0023-00",
"ProductNDC": "50090-0023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19860710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062677",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) capsules and tablets for oral administration. The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Doxycycline hyclate has the following structural formula. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg doxycycline (anhydrous). Inactive ingredients for capsules are: anhydrous lactose, croscarmellose sodium, FD&C Blue #1, gelatin, magnesium stearate, microcrystalline cellulose, and titanium dioxide. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg doxycycline. Inactive ingredients for tablets are: anhydrous lactose, carnauba wax, croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide."
}
]
}
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<NDCCode>50090-1820-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50090-1820-0) * 1 mL in 1 VIAL, GLASS (63851-511-11) * 1 mL in 1 SYRINGE (63851-512-12) </PackageDescription>
<NDC11Code>50090-1820-00</NDC11Code>
<ProductNDC>50090-1820</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Rabavert</ProprietaryName>
<NonProprietaryName>Rabies Vaccine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140708</StartMarketingDate>
<EndMarketingDate>20200331</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103334</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140708</StartMarketingDatePackage>
<EndMarketingDatePackage>20200331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>70518-1820-0</NDCCode>
<PackageDescription>30 POUCH in 1 BOX, UNIT-DOSE (70518-1820-0) > 1 TABLET in 1 POUCH (70518-1820-1) </PackageDescription>
<NDC11Code>70518-1820-00</NDC11Code>
<ProductNDC>70518-1820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076008</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>77768-1820-0</NDCCode>
<PackageDescription>3875 mL in 1 JUG (77768-1820-0) </PackageDescription>
<NDC11Code>77768-1820-00</NDC11Code>
<ProductNDC>77768-1820</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clean Up By Katom Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200322</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>KaTom Restaurant Supply, INC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68071-1820-2</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (68071-1820-2) </PackageDescription>
<NDC11Code>68071-1820-02</NDC11Code>
<ProductNDC>68071-1820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060456</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Penicillin V potassium tablets and penicillin V potassium for oral solution are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal infections (without bacteremia). Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant. Pneumococcal infections. Mild to moderately severe infections of the respiratory tract. Staphylococcal infections—penicillin G-sensitive. Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis)—Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium tablets, penicillin V potassium for oral solution, and other antibacterial drugs, penicillin V potassium tablets and penicillin V potassium for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Each penicillin V potassium tablet, USP contains penicillin V potassium equivalent to 250 mg (400,000 units) or 500 mg (800,000 units) penicillin V. The inactive ingredients present are dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Each penicillin V potassium tablet, USP, 250 mg contains 0.71 mEq (27.9 mg) of potassium and each penicillin V potassium tablet, USP, 500 mg contains 1.43 mEq (55.8 mg) of potassium. Penicillin V potassium for oral solution, USP is an off-white to pinkish colored powder, which when reconstituted as directed, yields a red colored solution with cherry flavor in which each 5 mL contains penicillin V potassium equivalent to 125 mg (200,000 units) or 250 mg (400,000 units) penicillin V. The inactive ingredients present are cherry flavor, FD&C Red #40, saccharin sodium, sodium benzoate, and sugar. Each 5 mL of reconstituted penicillin V potassium for oral solution, USP, 125 mg (200,000 units) per 5 mL contains 0.36 mEq (13.9 mg) of potassium. Each 5 mL of reconstituted penicillin V potassium for oral solution, USP, 250 mg (400,000 units) per 5 mL contains 0.71 mEq (27.9 mg) of potassium. Monopotassium (2 S,5 R,6 R)-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.</Description>
</NDC>
<NDC>
<NDCCode>71335-1820-1</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-1) </PackageDescription>
<NDC11Code>71335-1820-01</NDC11Code>
<ProductNDC>71335-1820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203203</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).</IndicationAndUsage>
<Description>The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>71335-1820-2</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-2) </PackageDescription>
<NDC11Code>71335-1820-02</NDC11Code>
<ProductNDC>71335-1820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203203</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).</IndicationAndUsage>
<Description>The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>71335-1820-3</NDCCode>
<PackageDescription>18 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-3) </PackageDescription>
<NDC11Code>71335-1820-03</NDC11Code>
<ProductNDC>71335-1820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203203</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
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<IndicationAndUsage>Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).</IndicationAndUsage>
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<Description>The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac.</Description>
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<IndicationAndUsage>Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).</IndicationAndUsage>
<Description>The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac.</Description>
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<Description>The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac.</Description>
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<IndicationAndUsage>Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).</IndicationAndUsage>
<Description>The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac.</Description>
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<IndicationAndUsage>Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).</IndicationAndUsage>
<Description>The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac.</Description>
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<IndicationAndUsage>Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Maintenance of healed duodenal ulcers in adults (1.3), 4 Treatment of active benign gastric ulcer in adults (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults (1.10).</IndicationAndUsage>
<Description>The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole Delayed-Release Capsules, USP are supplied in delayed-release capsules for oral administration.The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: methacrylic acid copolymer dispersion, hypromellose, magnesium carbonate, mannitol, polyethylene glycol, polysorbate, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, titanium dioxide. The capsule shell contains FD&C blue #2, gelatin, titanium dioxide and yellow iron oxide. Capsules are printed with edible black ink which contains black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol and shellac.</Description>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily : 1 reduces fever , 2 relieves minor aches, pains, and headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-0002-0</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (50090-0002-0) </PackageDescription>
<NDC11Code>50090-0002-00</NDC11Code>
<ProductNDC>50090-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pharbest Regular Strength Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-0004-0</NDCCode>
<PackageDescription>15 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0004-0) </PackageDescription>
<NDC11Code>50090-0004-00</NDC11Code>
<ProductNDC>50090-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pharbest Aspirin 325mg</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100920</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-0005-0</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50090-0005-0) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50090-0005-00</NDC11Code>
<ProductNDC>50090-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tylenol Extra Strength</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840819</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: the common coldheadachebackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-0007-0</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (50090-0007-0)</PackageDescription>
<NDC11Code>50090-0007-00</NDC11Code>
<ProductNDC>50090-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089805</ApplicationNumber>
<LabelerName>A-S Medication Solutions LLC</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>30; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>50090-0009-0</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (50090-0009-0)</PackageDescription>
<NDC11Code>50090-0009-00</NDC11Code>
<ProductNDC>50090-0009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089805</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>30; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-06-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>50090-0010-0</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (50090-0010-0)</PackageDescription>
<NDC11Code>50090-0010-00</NDC11Code>
<ProductNDC>50090-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078060</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>50090-0011-0</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (50090-0011-0)</PackageDescription>
<NDC11Code>50090-0011-00</NDC11Code>
<ProductNDC>50090-0011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078060</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>50090-0015-0</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (50090-0015-0)</PackageDescription>
<NDC11Code>50090-0015-00</NDC11Code>
<ProductNDC>50090-0015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-11</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-0016-0</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (50090-0016-0)</PackageDescription>
<NDC11Code>50090-0016-00</NDC11Code>
<ProductNDC>50090-0016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>A-S Medication Solutions LLC</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-0017-0</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (50090-0017-0)</PackageDescription>
<NDC11Code>50090-0017-00</NDC11Code>
<ProductNDC>50090-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>A-S Medication Solutions LLC</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-0018-0</NDCCode>
<PackageDescription>6 TABLET in 1 BOTTLE (50090-0018-0)</PackageDescription>
<NDC11Code>50090-0018-00</NDC11Code>
<ProductNDC>50090-0018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>A-S Medication Solutions LLC</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-0019-0</NDCCode>
<PackageDescription>6 TABLET in 1 BOTTLE (50090-0019-0)</PackageDescription>
<NDC11Code>50090-0019-00</NDC11Code>
<ProductNDC>50090-0019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-0020-0</NDCCode>
<PackageDescription>16 CAPSULE in 1 BOTTLE (50090-0020-0) </PackageDescription>
<NDC11Code>50090-0020-00</NDC11Code>
<ProductNDC>50090-0020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amantadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071293</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.</IndicationAndUsage>
<Description>Amantadine hydrochloride, USP is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride, USP has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride, USP is available as 100 mg capsules for oral administration. Inactive ingredients: corn starch, croscarmellose sodium, ethylcellulose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The capsule shells and imprinting ink contain: ammonium hydroxide,FD&C Blue #1, FD&C Red #40, gelatin, methylparaben, propylene glycol, propylparaben, shellac, simethicone, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-0021-0</NDCCode>
<PackageDescription>10 TABLET, COATED in 1 BOTTLE (50090-0021-0)</PackageDescription>
<NDC11Code>50090-0021-00</NDC11Code>
<ProductNDC>50090-0021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>A-S Medication Solutions LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-0022-0</NDCCode>
<PackageDescription>6 TABLET, COATED in 1 BOTTLE (50090-0022-0) </PackageDescription>
<NDC11Code>50090-0022-00</NDC11Code>
<ProductNDC>50090-0022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-0023-0</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-0023-0) </PackageDescription>
<NDC11Code>50090-0023-00</NDC11Code>
<ProductNDC>50090-0023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062677</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) capsules and tablets for oral administration. The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Doxycycline hyclate has the following structural formula. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg doxycycline (anhydrous). Inactive ingredients for capsules are: anhydrous lactose, croscarmellose sodium, FD&C Blue #1, gelatin, magnesium stearate, microcrystalline cellulose, and titanium dioxide. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg doxycycline. Inactive ingredients for tablets are: anhydrous lactose, carnauba wax, croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
</NDC>
</NDCList>