{
"NDC": [
{
"NDCCode": "15197-008-46",
"PackageDescription": "1 TUBE in 1 PACKAGE (15197-008-46) > 12.8 g in 1 TUBE (15197-008-45)",
"NDC11Code": "15197-0008-46",
"ProductNDC": "15197-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chamois Glide",
"NonProprietaryName": "Allantoin",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091124",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "W STERNOFF LLC",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather. temporarily protects minor cuts, scrapes, burns."
},
{
"NDCCode": "15197-007-46",
"PackageDescription": "1 TUBE in 1 PACKAGE (15197-007-46) > 12.8 g in 1 TUBE (15197-007-45)",
"NDC11Code": "15197-0007-46",
"ProductNDC": "15197-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bodyglide Anti Chafe Balm",
"NonProprietaryName": "Allantoin",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091124",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "W STERNOFF LLC",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "15197-008-14",
"PackageDescription": "1 TUBE in 1 PACKAGE (15197-008-14) > 36.9 g in 1 TUBE (15197-008-13)",
"NDC11Code": "15197-0008-14",
"ProductNDC": "15197-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chamois Glide",
"NonProprietaryName": "Allantoin",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091124",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "W STERNOFF LLC",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather. temporarily protects minor cuts, scrapes, burns."
},
{
"NDCCode": "15197-008-26",
"PackageDescription": "1 TUBE in 1 PACKAGE (15197-008-26) > 70 g in 1 TUBE (15197-008-25)",
"NDC11Code": "15197-0008-26",
"ProductNDC": "15197-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chamois Glide",
"NonProprietaryName": "Allantoin",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091124",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "W STERNOFF LLC",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather. temporarily protects minor cuts, scrapes, burns."
},
{
"NDCCode": "14961-008-03",
"PackageDescription": "12374.46 L in 1 CYLINDER (14961-008-03) ",
"NDC11Code": "14961-0008-03",
"ProductNDC": "14961-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbon Dioxide",
"NonProprietaryName": "Carbon Dioxide",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20211018",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205764",
"LabelerName": "Haun Specialty Gases, Inc.",
"SubstanceName": "CARBON DIOXIDE",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20211018",
"SamplePackage": "N"
},
{
"NDCCode": "41701-008-46",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (41701-008-46) > .8 g in 1 BOTTLE, PLASTIC (41701-008-45) ",
"NDC11Code": "41701-0008-46",
"ProductNDC": "41701-008",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Vasopressin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160328",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Hemmo Pharmaceuticals Pvt. Ltd",
"SubstanceName": "VASOPRESSIN, UNSPECIFIED",
"StrengthNumber": ".8",
"StrengthUnit": "g/.8g",
"Status": "Unfinished",
"LastUpdate": "2021-12-11",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "28-MAR-16"
},
{
"NDCCode": "71589-008-46",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (71589-008-46) > 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "71589-0008-46",
"ProductNDC": "71589-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213508",
"LabelerName": "Aleor Dermaceuticals Limited",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200626",
"SamplePackage": "N",
"IndicationAndUsage": "Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "Adapalene Gel USP, 0.3% contains adapalene USP, 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbopol 980, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene, USP is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene, USP is represented by the following structural formula."
},
{
"NDCCode": "80948-008-46",
"PackageDescription": "12 BOTTLE in 1 PACKAGE (80948-008-46) > 350 mL in 1 BOTTLE",
"NDC11Code": "80948-0008-46",
"ProductNDC": "80948-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Puroma Instant Foaming Hand Sanitizer Without Fragrance",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210310",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ZENITH MICRO CONTROL",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210310",
"SamplePackage": "N"
},
{
"NDCCode": "31722-403-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (31722-403-60) ",
"NDC11Code": "31722-0403-60",
"ProductNDC": "31722-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lubiprostone",
"NonProprietaryName": "Lubiprostone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218640",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LUBIPROSTONE",
"StrengthNumber": ".008",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250527",
"SamplePackage": "N",
"Description": "Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (-)-7-[(2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C20H32F2O5 with a molecular weight of 390.46 g/mol. and a chemical structure as follows. Lubiprostone drug substance occurs as white to off-white powder, is very soluble in diethyl ether and ethanol, and practically insoluble in hexane and water. Lubiprostone capsules is available as an imprinted, oval, soft gelatin capsule in two strengths. Light orange oval capsules contain 8 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, titanium dioxide, medium chain triglycerides, purified water and lecithin. Clear orange oval capsules contain 24 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, medium chain triglycerides, purified water and lecithin. The capsules are imprinted with black imprinting ink containing black iron oxide, propylene glycol, and hypromellose."
},
{
"NDCCode": "43602-548-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (43602-548-05) ",
"NDC11Code": "43602-0548-05",
"ProductNDC": "43602-548",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lubiprostone",
"NonProprietaryName": "Lubiprostone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218640",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "LUBIPROSTONE",
"StrengthNumber": ".008",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250102",
"SamplePackage": "N",
"Description": "Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (-)-7-[(2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C20H32F2O5 with a molecular weight of 390.46 g/mol. and a chemical structure as follows. Lubiprostone drug substance occurs as white to off-white powder, is very soluble in diethyl ether and ethanol, and practically insoluble in hexane and water. Lubiprostone capsules is available as an imprinted, oval, soft gelatin capsule in two strengths. Light orange oval capsules contain 8 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, titanium dioxide, medium chain triglycerides, purified water and lecithin. Clear orange oval capsules contain 24 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, medium chain triglycerides, purified water and lecithin. The capsules are imprinted with black imprinting ink containing black iron oxide, propylene glycol, and hypromellose."
},
{
"NDCCode": "43602-548-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (43602-548-30) ",
"NDC11Code": "43602-0548-30",
"ProductNDC": "43602-548",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lubiprostone",
"NonProprietaryName": "Lubiprostone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218640",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "LUBIPROSTONE",
"StrengthNumber": ".008",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250102",
"SamplePackage": "N",
"Description": "Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (-)-7-[(2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C20H32F2O5 with a molecular weight of 390.46 g/mol. and a chemical structure as follows. Lubiprostone drug substance occurs as white to off-white powder, is very soluble in diethyl ether and ethanol, and practically insoluble in hexane and water. Lubiprostone capsules is available as an imprinted, oval, soft gelatin capsule in two strengths. Light orange oval capsules contain 8 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, titanium dioxide, medium chain triglycerides, purified water and lecithin. Clear orange oval capsules contain 24 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, medium chain triglycerides, purified water and lecithin. The capsules are imprinted with black imprinting ink containing black iron oxide, propylene glycol, and hypromellose."
},
{
"NDCCode": "52667-008-30",
"PackageDescription": "30 mL in 1 BOTTLE (52667-008-30) ",
"NDC11Code": "52667-0008-30",
"ProductNDC": "52667-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bb Shade",
"ProprietaryNameSuffix": "20 Aglow Spf15",
"NonProprietaryName": "Zinc Oxide, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171221",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Purity Cosmetics",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "46; 87",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20171221",
"SamplePackage": "N",
"IndicationAndUsage": "evens skin tone while protecting against sun's UVA + UVB rays."
},
{
"NDCCode": "71209-008-03",
"PackageDescription": "60 TABLET in 1 BOTTLE (71209-008-03) ",
"NDC11Code": "71209-0008-03",
"ProductNDC": "71209-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203266",
"LabelerName": "Cadila Pharmaceuticals Limited",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181017",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of Gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROLAS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.",
"Description": "Gemfibrozil tablets, USP 600 mg is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; microcrystalline cellulose, NF; hydroxypropyl cellulose, NF; polysorbate 80, NF; colloidal silicon dioxide, NF; pregelatinized starch (maize starch), NF; croscarmellose sodium, NF; opadry white; opacode Blue. opadry white contains hypromellose, titanium dioxide, polyethylene glycol 400 and opacode blue contains shellac, FD&C Blue #1, N-butyl alcohol, titanium dioxide, propylene glycol, isopropyl alcohol. The chemical name is 5-(2,5-dimethylphenoxy)-2,2 dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°–61° C. Gemfibrozil, USP is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "71209-008-08",
"PackageDescription": "180 TABLET in 1 BOTTLE (71209-008-08) ",
"NDC11Code": "71209-0008-08",
"ProductNDC": "71209-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203266",
"LabelerName": "Cadila Pharmaceuticals Limited",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181017",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of Gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROLAS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.",
"Description": "Gemfibrozil tablets, USP 600 mg is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; microcrystalline cellulose, NF; hydroxypropyl cellulose, NF; polysorbate 80, NF; colloidal silicon dioxide, NF; pregelatinized starch (maize starch), NF; croscarmellose sodium, NF; opadry white; opacode Blue. opadry white contains hypromellose, titanium dioxide, polyethylene glycol 400 and opacode blue contains shellac, FD&C Blue #1, N-butyl alcohol, titanium dioxide, propylene glycol, isopropyl alcohol. The chemical name is 5-(2,5-dimethylphenoxy)-2,2 dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°–61° C. Gemfibrozil, USP is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "71209-008-10",
"PackageDescription": "500 TABLET in 1 BOTTLE (71209-008-10) ",
"NDC11Code": "71209-0008-10",
"ProductNDC": "71209-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203266",
"LabelerName": "Cadila Pharmaceuticals Limited",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181017",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of Gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROLAS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.",
"Description": "Gemfibrozil tablets, USP 600 mg is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; microcrystalline cellulose, NF; hydroxypropyl cellulose, NF; polysorbate 80, NF; colloidal silicon dioxide, NF; pregelatinized starch (maize starch), NF; croscarmellose sodium, NF; opadry white; opacode Blue. opadry white contains hypromellose, titanium dioxide, polyethylene glycol 400 and opacode blue contains shellac, FD&C Blue #1, N-butyl alcohol, titanium dioxide, propylene glycol, isopropyl alcohol. The chemical name is 5-(2,5-dimethylphenoxy)-2,2 dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°–61° C. Gemfibrozil, USP is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "72603-288-01",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (72603-288-01) ",
"NDC11Code": "72603-0288-01",
"ProductNDC": "72603-288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lubiprostone",
"NonProprietaryName": "Lubiprostone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218640",
"LabelerName": "Northstar Rx LLC",
"SubstanceName": "LUBIPROSTONE",
"StrengthNumber": ".008",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"Description": "Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (-)-7-[(2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C20H32F2O5 with a molecular weight of 390.46 g/mol. and a chemical structure as follows. Lubiprostone drug substance occurs as white to off-white powder, is very soluble in diethyl ether and ethanol, and practically insoluble in hexane and water. Lubiprostone capsules is available as an imprinted, oval, soft gelatin capsule in two strengths. Light orange oval capsules contain 8 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, titanium dioxide, medium chain triglycerides, purified water and lecithin. Clear orange oval capsules contain 24 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, medium chain triglycerides, purified water and lecithin. The capsules are imprinted with black imprinting ink containing black iron oxide, propylene glycol, and hypromellose."
},
{
"NDCCode": "73043-008-01",
"PackageDescription": "75 mL in 1 BOTTLE (73043-008-01) ",
"NDC11Code": "73043-0008-01",
"ProductNDC": "73043-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209351",
"LabelerName": "Devatis Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with: 1 Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors:Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)].",
"Description": "Amoxicillin and clavulanate potassium for oral suspension USP, is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S-3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the Trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Powder for oral suspension - carboxymethylcellulose sodium, sucralose, sodium citrate, anhydrous citric acid, silicon dioxide, colloidal silicon dioxide, xanthan gum, vanilla flavor (maltodextrin, glyceryl triacetate, corn starch, flavoring components), tutti frutti flavor (maltodextrin, propylene glycol, alpha tocopherol, flavoring components). Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains contains approximately 9 mg of potassium and 6 mg of sodium."
},
{
"NDCCode": "73043-008-02",
"PackageDescription": "125 mL in 1 BOTTLE (73043-008-02) ",
"NDC11Code": "73043-0008-02",
"ProductNDC": "73043-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209351",
"LabelerName": "Devatis Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with: 1 Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors:Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)].",
"Description": "Amoxicillin and clavulanate potassium for oral suspension USP, is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S-3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the Trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Powder for oral suspension - carboxymethylcellulose sodium, sucralose, sodium citrate, anhydrous citric acid, silicon dioxide, colloidal silicon dioxide, xanthan gum, vanilla flavor (maltodextrin, glyceryl triacetate, corn starch, flavoring components), tutti frutti flavor (maltodextrin, propylene glycol, alpha tocopherol, flavoring components). Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains contains approximately 9 mg of potassium and 6 mg of sodium."
},
{
"NDCCode": "73043-008-03",
"PackageDescription": "200 mL in 1 BOTTLE (73043-008-03) ",
"NDC11Code": "73043-0008-03",
"ProductNDC": "73043-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209351",
"LabelerName": "Devatis Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with: 1 Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors:Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)].",
"Description": "Amoxicillin and clavulanate potassium for oral suspension USP, is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S-3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the Trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Powder for oral suspension - carboxymethylcellulose sodium, sucralose, sodium citrate, anhydrous citric acid, silicon dioxide, colloidal silicon dioxide, xanthan gum, vanilla flavor (maltodextrin, glyceryl triacetate, corn starch, flavoring components), tutti frutti flavor (maltodextrin, propylene glycol, alpha tocopherol, flavoring components). Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains contains approximately 9 mg of potassium and 6 mg of sodium."
},
{
"NDCCode": "73362-008-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-008-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-008-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0008-01",
"ProductNDC": "73362-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
"StrengthNumber": "7.6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "15197-007-07",
"PackageDescription": "2 g in 1 TUBE (15197-007-07)",
"NDC11Code": "15197-0007-07",
"ProductNDC": "15197-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bodyglide Anti Chafe Balm",
"NonProprietaryName": "Allantoin",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091124",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "W STERNOFF LLC",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "15197-007-14",
"PackageDescription": "1 TUBE in 1 PACKAGE (15197-007-14) > 36.9 g in 1 TUBE (15197-007-13)",
"NDC11Code": "15197-0007-14",
"ProductNDC": "15197-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bodyglide Anti Chafe Balm",
"NonProprietaryName": "Allantoin",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091124",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "W STERNOFF LLC",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "15197-007-26",
"PackageDescription": "1 TUBE in 1 PACKAGE (15197-007-26) > 70 g in 1 TUBE (15197-007-25)",
"NDC11Code": "15197-0007-26",
"ProductNDC": "15197-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bodyglide Anti Chafe Balm",
"NonProprietaryName": "Allantoin",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091124",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "W STERNOFF LLC",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "15197-009-81",
"PackageDescription": "1 TUBE in 1 PACKAGE (15197-009-81) > 22.68 g in 1 TUBE (15197-009-80)",
"NDC11Code": "15197-0009-81",
"ProductNDC": "15197-009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bodyglide For Her",
"NonProprietaryName": "Allantoin",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091124",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "W STERNOFF LLC",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather. temporarily protects minor cuts, scrapes, burns."
},
{
"NDCCode": "0003-3734-13",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3734-13) / 24 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00003-3734-13",
"ProductNDC": "0003-3734",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Opdivo",
"NonProprietaryName": "Nivolumab",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20171208",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125554",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "NIVOLUMAB",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171208",
"SamplePackage": "N",
"IndicationAndUsage": "OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of:. Melanoma: 1 adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2).",
"Description": "Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody. Nivolumab is an IgG4 kappa immunoglobulin that has a calculated molecular mass of 146 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. OPDIVO is a sterile, preservative-free, non-pyrogenic, clear to opalescent, colorless to pale-yellow liquid that may contain light (few) particles. OPDIVO (nivolumab) injection for intravenous use is supplied in single-dose vials. Each mL of OPDIVO solution contains nivolumab 10 mg, mannitol (30 mg), pentetic acid (0.008 mg), polysorbate 80 (0.2 mg), sodium chloride (2.92 mg), sodium citrate dihydrate (5.88 mg), and Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide to adjust pH to 6."
},
{
"NDCCode": "0003-3756-14",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3756-14) / 12 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00003-3756-14",
"ProductNDC": "0003-3756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Opdivo",
"NonProprietaryName": "Nivolumab",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210830",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125554",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "NIVOLUMAB",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210830",
"SamplePackage": "N",
"IndicationAndUsage": "OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of:. Melanoma: 1 adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2).",
"Description": "Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody. Nivolumab is an IgG4 kappa immunoglobulin that has a calculated molecular mass of 146 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. OPDIVO is a sterile, preservative-free, non-pyrogenic, clear to opalescent, colorless to pale-yellow liquid that may contain light (few) particles. OPDIVO (nivolumab) injection for intravenous use is supplied in single-dose vials. Each mL of OPDIVO solution contains nivolumab 10 mg, mannitol (30 mg), pentetic acid (0.008 mg), polysorbate 80 (0.2 mg), sodium chloride (2.92 mg), sodium citrate dihydrate (5.88 mg), and Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide to adjust pH to 6."
},
{
"NDCCode": "0003-3772-11",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3772-11) / 4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00003-3772-11",
"ProductNDC": "0003-3772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Opdivo",
"NonProprietaryName": "Nivolumab",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125554",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "NIVOLUMAB",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141222",
"SamplePackage": "N",
"IndicationAndUsage": "OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of:. Melanoma: 1 adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2).",
"Description": "Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody. Nivolumab is an IgG4 kappa immunoglobulin that has a calculated molecular mass of 146 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. OPDIVO is a sterile, preservative-free, non-pyrogenic, clear to opalescent, colorless to pale-yellow liquid that may contain light (few) particles. OPDIVO (nivolumab) injection for intravenous use is supplied in single-dose vials. Each mL of OPDIVO solution contains nivolumab 10 mg, mannitol (30 mg), pentetic acid (0.008 mg), polysorbate 80 (0.2 mg), sodium chloride (2.92 mg), sodium citrate dihydrate (5.88 mg), and Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide to adjust pH to 6."
},
{
"NDCCode": "0003-3774-12",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3774-12) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00003-3774-12",
"ProductNDC": "0003-3774",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Opdivo",
"NonProprietaryName": "Nivolumab",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125554",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "NIVOLUMAB",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141222",
"SamplePackage": "N",
"IndicationAndUsage": "OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of:. Melanoma: 1 adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2).",
"Description": "Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody. Nivolumab is an IgG4 kappa immunoglobulin that has a calculated molecular mass of 146 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. OPDIVO is a sterile, preservative-free, non-pyrogenic, clear to opalescent, colorless to pale-yellow liquid that may contain light (few) particles. OPDIVO (nivolumab) injection for intravenous use is supplied in single-dose vials. Each mL of OPDIVO solution contains nivolumab 10 mg, mannitol (30 mg), pentetic acid (0.008 mg), polysorbate 80 (0.2 mg), sodium chloride (2.92 mg), sodium citrate dihydrate (5.88 mg), and Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide to adjust pH to 6."
},
{
"NDCCode": "0003-7125-11",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0003-7125-11) / 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00003-7125-11",
"ProductNDC": "0003-7125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Opdualag",
"NonProprietaryName": "Nivolumab And Relatlimab-rmbw",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220318",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761234",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "NIVOLUMAB; RELATLIMAB",
"StrengthNumber": "12; 4",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Lymphocyte Activation Gene-3 Antagonists [MoA], Lymphocyte Activation Gene-3 Blocker [EPC], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220318",
"SamplePackage": "N",
"IndicationAndUsage": "OPDUALAG is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.",
"Description": "Nivolumab and relatlimab-rmbw is a fixed-dose combination of two IgG4 kappa monoclonal antibodies (mAbs). Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody that has a calculated molecular mass of 146 kDa and is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Relatlimab is a lymphocyte activation gene-3 (LAG-3) blocking antibody that has a calculated molecular mass of 148 kDa and is expressed in a recombinant CHO cell line. OPDUALAG (nivolumab and relatlimab-rmbw) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution that may contain few translucent-to-white particles. OPDUALAG is supplied as 240 mg of nivolumab and 80 mg of relatlimab in a 20 mL single-dose vial for intravenous use. Each mL of OPDUALAG solution contains 12 mg of nivolumab, 4 mg of relatlimab, and histidine (1.1 mg), L-histidine hydrochloride monohydrate (2.7 mg), pentetic acid (0.008 mg), polysorbate 80 (0.5 mg), sucrose (85.6 mg), and Water for Injection, USP. The pH is 5.8."
},
{
"NDCCode": "0404-9768-30",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9768-30) / 30 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00404-9768-30",
"ProductNDC": "0404-9768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Marcaine",
"NonProprietaryName": "Bupivacine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20260126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016964",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260126",
"SamplePackage": "N",
"IndicationAndUsage": "MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use. Not all blocks are indicated for use with MARCAINE / MARCAINE WITH EPINEPHRINE given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].",
"Description": "MARCAINE / MARCAINE WITH EPINEPHRINE contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for MARCAINE (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for MARCAINE WITH EPINEPHRINE is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. MARCAINE with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine bitartrate (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine bitartrate is (–) - 3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol (+)-tartrate (1:1) salt. Epinephrine is a vasoconstrictor. It has the following structural formula. MARCAINE (bupivacaine hydrochloride) is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. MARCAINE with epinephrine 1:200,000 (as bitartrate) is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.0091 mg epinephrine bitartrate (equivalent to 0.005 mg of epinephrine), with sodium chloride for isotonicity, 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>15197-008-46</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (15197-008-46) > 12.8 g in 1 TUBE (15197-008-45)</PackageDescription>
<NDC11Code>15197-0008-46</NDC11Code>
<ProductNDC>15197-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chamois Glide</ProprietaryName>
<NonProprietaryName>Allantoin</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091124</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>W STERNOFF LLC</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather. temporarily protects minor cuts, scrapes, burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15197-007-46</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (15197-007-46) > 12.8 g in 1 TUBE (15197-007-45)</PackageDescription>
<NDC11Code>15197-0007-46</NDC11Code>
<ProductNDC>15197-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bodyglide Anti Chafe Balm</ProprietaryName>
<NonProprietaryName>Allantoin</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091124</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>W STERNOFF LLC</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15197-008-14</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (15197-008-14) > 36.9 g in 1 TUBE (15197-008-13)</PackageDescription>
<NDC11Code>15197-0008-14</NDC11Code>
<ProductNDC>15197-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chamois Glide</ProprietaryName>
<NonProprietaryName>Allantoin</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091124</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>W STERNOFF LLC</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather. temporarily protects minor cuts, scrapes, burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15197-008-26</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (15197-008-26) > 70 g in 1 TUBE (15197-008-25)</PackageDescription>
<NDC11Code>15197-0008-26</NDC11Code>
<ProductNDC>15197-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chamois Glide</ProprietaryName>
<NonProprietaryName>Allantoin</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091124</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>W STERNOFF LLC</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather. temporarily protects minor cuts, scrapes, burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14961-008-03</NDCCode>
<PackageDescription>12374.46 L in 1 CYLINDER (14961-008-03) </PackageDescription>
<NDC11Code>14961-0008-03</NDC11Code>
<ProductNDC>14961-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbon Dioxide</ProprietaryName>
<NonProprietaryName>Carbon Dioxide</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20211018</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205764</ApplicationNumber>
<LabelerName>Haun Specialty Gases, Inc.</LabelerName>
<SubstanceName>CARBON DIOXIDE</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41701-008-46</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (41701-008-46) > .8 g in 1 BOTTLE, PLASTIC (41701-008-45) </PackageDescription>
<NDC11Code>41701-0008-46</NDC11Code>
<ProductNDC>41701-008</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Vasopressin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160328</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Hemmo Pharmaceuticals Pvt. Ltd</LabelerName>
<SubstanceName>VASOPRESSIN, UNSPECIFIED</SubstanceName>
<StrengthNumber>.8</StrengthNumber>
<StrengthUnit>g/.8g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2021-12-11</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>28-MAR-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71589-008-46</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (71589-008-46) > 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>71589-0008-46</NDC11Code>
<ProductNDC>71589-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213508</ApplicationNumber>
<LabelerName>Aleor Dermaceuticals Limited</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.</IndicationAndUsage>
<Description>Adapalene Gel USP, 0.3% contains adapalene USP, 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbopol 980, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene, USP is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene, USP is represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>80948-008-46</NDCCode>
<PackageDescription>12 BOTTLE in 1 PACKAGE (80948-008-46) > 350 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>80948-0008-46</NDC11Code>
<ProductNDC>80948-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Puroma Instant Foaming Hand Sanitizer Without Fragrance</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210310</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ZENITH MICRO CONTROL</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>31722-403-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (31722-403-60) </PackageDescription>
<NDC11Code>31722-0403-60</NDC11Code>
<ProductNDC>31722-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lubiprostone</ProprietaryName>
<NonProprietaryName>Lubiprostone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218640</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LUBIPROSTONE</SubstanceName>
<StrengthNumber>.008</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (-)-7-[(2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C20H32F2O5 with a molecular weight of 390.46 g/mol. and a chemical structure as follows. Lubiprostone drug substance occurs as white to off-white powder, is very soluble in diethyl ether and ethanol, and practically insoluble in hexane and water. Lubiprostone capsules is available as an imprinted, oval, soft gelatin capsule in two strengths. Light orange oval capsules contain 8 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, titanium dioxide, medium chain triglycerides, purified water and lecithin. Clear orange oval capsules contain 24 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, medium chain triglycerides, purified water and lecithin. The capsules are imprinted with black imprinting ink containing black iron oxide, propylene glycol, and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>43602-548-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (43602-548-05) </PackageDescription>
<NDC11Code>43602-0548-05</NDC11Code>
<ProductNDC>43602-548</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lubiprostone</ProprietaryName>
<NonProprietaryName>Lubiprostone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218640</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LUBIPROSTONE</SubstanceName>
<StrengthNumber>.008</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (-)-7-[(2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C20H32F2O5 with a molecular weight of 390.46 g/mol. and a chemical structure as follows. Lubiprostone drug substance occurs as white to off-white powder, is very soluble in diethyl ether and ethanol, and practically insoluble in hexane and water. Lubiprostone capsules is available as an imprinted, oval, soft gelatin capsule in two strengths. Light orange oval capsules contain 8 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, titanium dioxide, medium chain triglycerides, purified water and lecithin. Clear orange oval capsules contain 24 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, medium chain triglycerides, purified water and lecithin. The capsules are imprinted with black imprinting ink containing black iron oxide, propylene glycol, and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>43602-548-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (43602-548-30) </PackageDescription>
<NDC11Code>43602-0548-30</NDC11Code>
<ProductNDC>43602-548</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lubiprostone</ProprietaryName>
<NonProprietaryName>Lubiprostone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218640</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LUBIPROSTONE</SubstanceName>
<StrengthNumber>.008</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (-)-7-[(2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C20H32F2O5 with a molecular weight of 390.46 g/mol. and a chemical structure as follows. Lubiprostone drug substance occurs as white to off-white powder, is very soluble in diethyl ether and ethanol, and practically insoluble in hexane and water. Lubiprostone capsules is available as an imprinted, oval, soft gelatin capsule in two strengths. Light orange oval capsules contain 8 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, titanium dioxide, medium chain triglycerides, purified water and lecithin. Clear orange oval capsules contain 24 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, medium chain triglycerides, purified water and lecithin. The capsules are imprinted with black imprinting ink containing black iron oxide, propylene glycol, and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>52667-008-30</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (52667-008-30) </PackageDescription>
<NDC11Code>52667-0008-30</NDC11Code>
<ProductNDC>52667-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bb Shade</ProprietaryName>
<ProprietaryNameSuffix>20 Aglow Spf15</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171221</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Purity Cosmetics</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>46; 87</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>evens skin tone while protecting against sun's UVA + UVB rays.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71209-008-03</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71209-008-03) </PackageDescription>
<NDC11Code>71209-0008-03</NDC11Code>
<ProductNDC>71209-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203266</ApplicationNumber>
<LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of Gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROLAS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
<Description>Gemfibrozil tablets, USP 600 mg is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; microcrystalline cellulose, NF; hydroxypropyl cellulose, NF; polysorbate 80, NF; colloidal silicon dioxide, NF; pregelatinized starch (maize starch), NF; croscarmellose sodium, NF; opadry white; opacode Blue. opadry white contains hypromellose, titanium dioxide, polyethylene glycol 400 and opacode blue contains shellac, FD&C Blue #1, N-butyl alcohol, titanium dioxide, propylene glycol, isopropyl alcohol. The chemical name is 5-(2,5-dimethylphenoxy)-2,2 dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°–61° C. Gemfibrozil, USP is a white solid which is stable under ordinary conditions.</Description>
</NDC>
<NDC>
<NDCCode>71209-008-08</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (71209-008-08) </PackageDescription>
<NDC11Code>71209-0008-08</NDC11Code>
<ProductNDC>71209-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203266</ApplicationNumber>
<LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of Gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROLAS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
<Description>Gemfibrozil tablets, USP 600 mg is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; microcrystalline cellulose, NF; hydroxypropyl cellulose, NF; polysorbate 80, NF; colloidal silicon dioxide, NF; pregelatinized starch (maize starch), NF; croscarmellose sodium, NF; opadry white; opacode Blue. opadry white contains hypromellose, titanium dioxide, polyethylene glycol 400 and opacode blue contains shellac, FD&C Blue #1, N-butyl alcohol, titanium dioxide, propylene glycol, isopropyl alcohol. The chemical name is 5-(2,5-dimethylphenoxy)-2,2 dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°–61° C. Gemfibrozil, USP is a white solid which is stable under ordinary conditions.</Description>
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<NDC>
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<ProprietaryName>Gemfibrozil</ProprietaryName>
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<ApplicationNumber>ANDA203266</ApplicationNumber>
<LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
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<LastUpdate>2022-12-29</LastUpdate>
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<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of Gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROLAS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
<Description>Gemfibrozil tablets, USP 600 mg is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; microcrystalline cellulose, NF; hydroxypropyl cellulose, NF; polysorbate 80, NF; colloidal silicon dioxide, NF; pregelatinized starch (maize starch), NF; croscarmellose sodium, NF; opadry white; opacode Blue. opadry white contains hypromellose, titanium dioxide, polyethylene glycol 400 and opacode blue contains shellac, FD&C Blue #1, N-butyl alcohol, titanium dioxide, propylene glycol, isopropyl alcohol. The chemical name is 5-(2,5-dimethylphenoxy)-2,2 dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°–61° C. Gemfibrozil, USP is a white solid which is stable under ordinary conditions.</Description>
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<NDC>
<NDCCode>72603-288-01</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (72603-288-01) </PackageDescription>
<NDC11Code>72603-0288-01</NDC11Code>
<ProductNDC>72603-288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lubiprostone</ProprietaryName>
<NonProprietaryName>Lubiprostone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218640</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<SubstanceName>LUBIPROSTONE</SubstanceName>
<StrengthNumber>.008</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-01</LastUpdate>
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<Description>Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (-)-7-[(2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C20H32F2O5 with a molecular weight of 390.46 g/mol. and a chemical structure as follows. Lubiprostone drug substance occurs as white to off-white powder, is very soluble in diethyl ether and ethanol, and practically insoluble in hexane and water. Lubiprostone capsules is available as an imprinted, oval, soft gelatin capsule in two strengths. Light orange oval capsules contain 8 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, titanium dioxide, medium chain triglycerides, purified water and lecithin. Clear orange oval capsules contain 24 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, medium chain triglycerides, purified water and lecithin. The capsules are imprinted with black imprinting ink containing black iron oxide, propylene glycol, and hypromellose.</Description>
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<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
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<ApplicationNumber>ANDA209351</ApplicationNumber>
<LabelerName>Devatis Inc.</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2025-03-15</LastUpdate>
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<IndicationAndUsage>Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with: 1 Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors:Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)].</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium for oral suspension USP, is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S-3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the Trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Powder for oral suspension - carboxymethylcellulose sodium, sucralose, sodium citrate, anhydrous citric acid, silicon dioxide, colloidal silicon dioxide, xanthan gum, vanilla flavor (maltodextrin, glyceryl triacetate, corn starch, flavoring components), tutti frutti flavor (maltodextrin, propylene glycol, alpha tocopherol, flavoring components). Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains contains approximately 9 mg of potassium and 6 mg of sodium.</Description>
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<NDC>
<NDCCode>73043-008-02</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (73043-008-02) </PackageDescription>
<NDC11Code>73043-0008-02</NDC11Code>
<ProductNDC>73043-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
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<StartMarketingDate>20241101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209351</ApplicationNumber>
<LabelerName>Devatis Inc.</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with: 1 Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors:Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)].</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium for oral suspension USP, is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S-3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the Trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Powder for oral suspension - carboxymethylcellulose sodium, sucralose, sodium citrate, anhydrous citric acid, silicon dioxide, colloidal silicon dioxide, xanthan gum, vanilla flavor (maltodextrin, glyceryl triacetate, corn starch, flavoring components), tutti frutti flavor (maltodextrin, propylene glycol, alpha tocopherol, flavoring components). Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains contains approximately 9 mg of potassium and 6 mg of sodium.</Description>
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<PackageDescription>200 mL in 1 BOTTLE (73043-008-03) </PackageDescription>
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<ProductNDC>73043-008</ProductNDC>
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<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
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<StartMarketingDate>20241101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209351</ApplicationNumber>
<LabelerName>Devatis Inc.</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with: 1 Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors:Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)].</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium for oral suspension USP, is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S-3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the Trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Powder for oral suspension - carboxymethylcellulose sodium, sucralose, sodium citrate, anhydrous citric acid, silicon dioxide, colloidal silicon dioxide, xanthan gum, vanilla flavor (maltodextrin, glyceryl triacetate, corn starch, flavoring components), tutti frutti flavor (maltodextrin, propylene glycol, alpha tocopherol, flavoring components). Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains contains approximately 9 mg of potassium and 6 mg of sodium.</Description>
</NDC>
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<NDCCode>73362-008-01</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (73362-008-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-008-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE</PackageDescription>
<NDC11Code>73362-0008-01</NDC11Code>
<ProductNDC>73362-008</ProductNDC>
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<ProprietaryName>Skytrofa</ProprietaryName>
<NonProprietaryName>Lonapegsomatropin-tcgd</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20210825</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761177</ApplicationNumber>
<LabelerName>Ascendis Pharma Endocrinology, Inc.</LabelerName>
<SubstanceName>LONAPEGSOMATROPIN</SubstanceName>
<StrengthNumber>7.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
</NDC>
<NDC>
<NDCCode>15197-007-07</NDCCode>
<PackageDescription>2 g in 1 TUBE (15197-007-07)</PackageDescription>
<NDC11Code>15197-0007-07</NDC11Code>
<ProductNDC>15197-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bodyglide Anti Chafe Balm</ProprietaryName>
<NonProprietaryName>Allantoin</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091124</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>W STERNOFF LLC</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15197-007-14</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (15197-007-14) > 36.9 g in 1 TUBE (15197-007-13)</PackageDescription>
<NDC11Code>15197-0007-14</NDC11Code>
<ProductNDC>15197-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bodyglide Anti Chafe Balm</ProprietaryName>
<NonProprietaryName>Allantoin</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091124</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>W STERNOFF LLC</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15197-007-26</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (15197-007-26) > 70 g in 1 TUBE (15197-007-25)</PackageDescription>
<NDC11Code>15197-0007-26</NDC11Code>
<ProductNDC>15197-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bodyglide Anti Chafe Balm</ProprietaryName>
<NonProprietaryName>Allantoin</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091124</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>W STERNOFF LLC</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15197-009-81</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (15197-009-81) > 22.68 g in 1 TUBE (15197-009-80)</PackageDescription>
<NDC11Code>15197-0009-81</NDC11Code>
<ProductNDC>15197-009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bodyglide For Her</ProprietaryName>
<NonProprietaryName>Allantoin</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091124</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>W STERNOFF LLC</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent and helps relieve chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather. temporarily protects minor cuts, scrapes, burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0003-3734-13</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3734-13) / 24 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00003-3734-13</NDC11Code>
<ProductNDC>0003-3734</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Opdivo</ProprietaryName>
<NonProprietaryName>Nivolumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20171208</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125554</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>NIVOLUMAB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of:. Melanoma: 1 adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2).</IndicationAndUsage>
<Description>Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody. Nivolumab is an IgG4 kappa immunoglobulin that has a calculated molecular mass of 146 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. OPDIVO is a sterile, preservative-free, non-pyrogenic, clear to opalescent, colorless to pale-yellow liquid that may contain light (few) particles. OPDIVO (nivolumab) injection for intravenous use is supplied in single-dose vials. Each mL of OPDIVO solution contains nivolumab 10 mg, mannitol (30 mg), pentetic acid (0.008 mg), polysorbate 80 (0.2 mg), sodium chloride (2.92 mg), sodium citrate dihydrate (5.88 mg), and Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide to adjust pH to 6.</Description>
</NDC>
<NDC>
<NDCCode>0003-3756-14</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3756-14) / 12 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00003-3756-14</NDC11Code>
<ProductNDC>0003-3756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Opdivo</ProprietaryName>
<NonProprietaryName>Nivolumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210830</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125554</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>NIVOLUMAB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of:. Melanoma: 1 adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2).</IndicationAndUsage>
<Description>Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody. Nivolumab is an IgG4 kappa immunoglobulin that has a calculated molecular mass of 146 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. OPDIVO is a sterile, preservative-free, non-pyrogenic, clear to opalescent, colorless to pale-yellow liquid that may contain light (few) particles. OPDIVO (nivolumab) injection for intravenous use is supplied in single-dose vials. Each mL of OPDIVO solution contains nivolumab 10 mg, mannitol (30 mg), pentetic acid (0.008 mg), polysorbate 80 (0.2 mg), sodium chloride (2.92 mg), sodium citrate dihydrate (5.88 mg), and Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide to adjust pH to 6.</Description>
</NDC>
<NDC>
<NDCCode>0003-3772-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3772-11) / 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00003-3772-11</NDC11Code>
<ProductNDC>0003-3772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Opdivo</ProprietaryName>
<NonProprietaryName>Nivolumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125554</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>NIVOLUMAB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of:. Melanoma: 1 adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2).</IndicationAndUsage>
<Description>Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody. Nivolumab is an IgG4 kappa immunoglobulin that has a calculated molecular mass of 146 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. OPDIVO is a sterile, preservative-free, non-pyrogenic, clear to opalescent, colorless to pale-yellow liquid that may contain light (few) particles. OPDIVO (nivolumab) injection for intravenous use is supplied in single-dose vials. Each mL of OPDIVO solution contains nivolumab 10 mg, mannitol (30 mg), pentetic acid (0.008 mg), polysorbate 80 (0.2 mg), sodium chloride (2.92 mg), sodium citrate dihydrate (5.88 mg), and Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide to adjust pH to 6.</Description>
</NDC>
<NDC>
<NDCCode>0003-3774-12</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3774-12) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00003-3774-12</NDC11Code>
<ProductNDC>0003-3774</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Opdivo</ProprietaryName>
<NonProprietaryName>Nivolumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125554</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>NIVOLUMAB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of:. Melanoma: 1 adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2).</IndicationAndUsage>
<Description>Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody. Nivolumab is an IgG4 kappa immunoglobulin that has a calculated molecular mass of 146 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. OPDIVO is a sterile, preservative-free, non-pyrogenic, clear to opalescent, colorless to pale-yellow liquid that may contain light (few) particles. OPDIVO (nivolumab) injection for intravenous use is supplied in single-dose vials. Each mL of OPDIVO solution contains nivolumab 10 mg, mannitol (30 mg), pentetic acid (0.008 mg), polysorbate 80 (0.2 mg), sodium chloride (2.92 mg), sodium citrate dihydrate (5.88 mg), and Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide to adjust pH to 6.</Description>
</NDC>
<NDC>
<NDCCode>0003-7125-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0003-7125-11) / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00003-7125-11</NDC11Code>
<ProductNDC>0003-7125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Opdualag</ProprietaryName>
<NonProprietaryName>Nivolumab And Relatlimab-rmbw</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220318</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761234</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>NIVOLUMAB; RELATLIMAB</SubstanceName>
<StrengthNumber>12; 4</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Lymphocyte Activation Gene-3 Antagonists [MoA], Lymphocyte Activation Gene-3 Blocker [EPC], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OPDUALAG is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.</IndicationAndUsage>
<Description>Nivolumab and relatlimab-rmbw is a fixed-dose combination of two IgG4 kappa monoclonal antibodies (mAbs). Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody that has a calculated molecular mass of 146 kDa and is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Relatlimab is a lymphocyte activation gene-3 (LAG-3) blocking antibody that has a calculated molecular mass of 148 kDa and is expressed in a recombinant CHO cell line. OPDUALAG (nivolumab and relatlimab-rmbw) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution that may contain few translucent-to-white particles. OPDUALAG is supplied as 240 mg of nivolumab and 80 mg of relatlimab in a 20 mL single-dose vial for intravenous use. Each mL of OPDUALAG solution contains 12 mg of nivolumab, 4 mg of relatlimab, and histidine (1.1 mg), L-histidine hydrochloride monohydrate (2.7 mg), pentetic acid (0.008 mg), polysorbate 80 (0.5 mg), sucrose (85.6 mg), and Water for Injection, USP. The pH is 5.8.</Description>
</NDC>
<NDC>
<NDCCode>0404-9768-30</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (0404-9768-30) / 30 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00404-9768-30</NDC11Code>
<ProductNDC>0404-9768</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Marcaine</ProprietaryName>
<NonProprietaryName>Bupivacine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20260126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016964</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use. Not all blocks are indicated for use with MARCAINE / MARCAINE WITH EPINEPHRINE given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].</IndicationAndUsage>
<Description>MARCAINE / MARCAINE WITH EPINEPHRINE contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for MARCAINE (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for MARCAINE WITH EPINEPHRINE is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. MARCAINE with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine bitartrate (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine bitartrate is (–) - 3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol (+)-tartrate (1:1) salt. Epinephrine is a vasoconstrictor. It has the following structural formula. MARCAINE (bupivacaine hydrochloride) is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. MARCAINE with epinephrine 1:200,000 (as bitartrate) is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.0091 mg epinephrine bitartrate (equivalent to 0.005 mg of epinephrine), with sodium chloride for isotonicity, 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008.</Description>
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