{
"NDC": [
{
"NDCCode": "49884-937-67",
"PackageDescription": "210 g in 1 CAN (49884-937-67) ",
"NDC11Code": "49884-0937-67",
"ProductNDC": "49884-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Questran",
"NonProprietaryName": "Cholestyramine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20030724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077203",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "CHOLESTYRAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/5g",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030724",
"SamplePackage": "N",
"IndicationAndUsage": "1) QUESTRAN (Cholestyramine for Oral Suspension USP), is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. QUESTRAN may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with QUESTRAN secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess Total cholesterol, HDL-C, and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total cholesterol – [(TG/5) + HDL-C]. For TG levels >400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases QUESTRAN may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of QUESTRAN therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of QUESTRAN or adding other lipid-lowering agents in combination with QUESTRAN should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. QUESTRAN monotherapy has been demonstrated to retard the rate of progression 2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) QUESTRAN is indicated for the relief of pruritus associated with partial biliary obstruction. QUESTRAN has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.",
"Description": "QUESTRAN ® (Cholestyramine for Oral Suspension USP), the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in QUESTRAN is not absorbed from the digestive tract. Four grams of anhydrous cholestyramine resin is contained in 9 grams of QUESTRAN powder. Four grams of anhydrous cholestyramine resin is contained in 5 grams of QUESTRAN LIGHT. It is represented by the following structural formula. QUESTRAN powder contains the following inactive ingredients: acacia, citric acid, D&C Yellow No. 10, FD&C Yellow No.6, flavor (natural and artificial Orange), polysorbate 80, propylene glycol alginate and sucrose. QUESTRAN LIGHT contains the following inactive ingredients: aspartame, citric acid, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Red No.40, flavor (natural and artificial Orange), maltodextrin, propylene glycol alginate and xanthan gum."
},
{
"NDCCode": "49884-937-65",
"PackageDescription": "60 PACKET in 1 CARTON (49884-937-65) > 5 g in 1 PACKET (49884-937-63)",
"NDC11Code": "49884-0937-65",
"ProductNDC": "49884-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Questran",
"NonProprietaryName": "Cholestyramine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20030724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077203",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "CHOLESTYRAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/5g",
"Pharm_Classes": "Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49884-466-67",
"PackageDescription": "210 g in 1 CAN (49884-466-67) ",
"NDC11Code": "49884-0466-67",
"ProductNDC": "49884-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cholestyramine",
"NonProprietaryName": "Cholestyramine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20050915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077203",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "CHOLESTYRAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/5g",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050915",
"SamplePackage": "N",
"IndicationAndUsage": "1) Cholestyramine for Oral Suspension USP is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with Cholestyramine, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess Total cholesterol, HDL-C, and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total cholesterol – [(TG/5) + HDL-C]. For TG levels >400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases Cholestyramine may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of Cholestyramine therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of Cholestyramine or adding other lipid-lowering agents in combination with Cholestyramine should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. Cholestyramine monotherapy has been demonstrated to retard the rate of progression 2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) Cholestyramine for oral suspension is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine for oral suspension has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.",
"Description": "Cholestyramine for Oral Suspension USP, the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in Cholestyramine is not absorbed from the digestive tract. Four grams of anhydrous cholestyramine resin is contained in 9 grams of Cholestyramine for Oral Suspension USP. Four grams of anhydrous cholestyramine resin is contained in 5 grams of Cholestyramine for Oral Suspension USP, Light. It is represented by the following structural formula. Cholestyramine for Oral Suspension USP contains the following inactive ingredients: acacia, citric acid, D&C Yellow No. 10, FD&C Yellow No. 6, flavor (natural and artificial Orange), polysorbate 80, propylene glycol alginate and sucrose. Cholestyramine for Oral Suspension USP, Light contains the following inactive ingredients: aspartame, citric acid, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Red No. 40, flavor (natural and artificial Orange), maltodextrin, propylene glycol alginate and xanthan gum."
},
{
"NDCCode": "49884-264-95",
"PackageDescription": "1 BOTTLE in 1 CARTON (49884-264-95) / 25 mL in 1 BOTTLE",
"NDC11Code": "49884-0264-95",
"ProductNDC": "49884-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycerol Phenylbutyrate",
"NonProprietaryName": "Glycerol Phenylbutyrate Oral",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20251017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205742",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "GLYCEROL PHENYLBUTYRATE",
"StrengthNumber": "1.1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251017",
"SamplePackage": "N",
"IndicationAndUsage": "Glycerol phenylbutyrate oral liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Glycerol phenylbutyrate oral liquid must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements). Limitations of Use: : 1 Glycerol phenylbutyrate oral liquid is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels. , 2 The safety and efficacy of glycerol phenylbutyrate oral liquid for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established. .",
"Description": "Glycerol phenylbutyrate is a clear, colorless to pale yellow oral liquid. It is soluble in dimethylsulfoxide (DMSO) and in dimethyl formamide. Glycerol phenylbutyrate is a nitrogen-binding agent. It is a triglyceride containing 3 molecules of PBA linked to a glycerol backbone, the chemical name of which is benzenebutanoic acid, 1', 1' ' –(1,2,3-propanetriyl) ester with a molecular weight of 530.67. It has a molecular formula of C33H38O6. The structural formula is."
},
{
"NDCCode": "49884-658-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (49884-658-09) ",
"NDC11Code": "49884-0658-09",
"ProductNDC": "49884-658",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Candesartan Cilexetil",
"NonProprietaryName": "Candesartan Cilexetil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130521",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020838",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "CANDESARTAN CILEXETIL",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130521",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). , 2 Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2).",
"Description": "Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C33H34N6O6, and its structural formula is. Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Candesartan cilexetil is available for oral use as tablets containing either 4 mg, 8 mg, 16 mg, or 32 mg of candesartan cilexetil and the following inactive ingredients: hydroxypropyl cellulose, polyethylene glycol, lactose, corn starch, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide (reddish brown) is added to the 8-mg, 16-mg, and 32-mg tablets as a colorant."
},
{
"NDCCode": "49884-659-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (49884-659-09) ",
"NDC11Code": "49884-0659-09",
"ProductNDC": "49884-659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Candesartan Cilexetil",
"NonProprietaryName": "Candesartan Cilexetil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130521",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020838",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "CANDESARTAN CILEXETIL",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130521",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). , 2 Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2).",
"Description": "Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C33H34N6O6, and its structural formula is. Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Candesartan cilexetil is available for oral use as tablets containing either 4 mg, 8 mg, 16 mg, or 32 mg of candesartan cilexetil and the following inactive ingredients: hydroxypropyl cellulose, polyethylene glycol, lactose, corn starch, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide (reddish brown) is added to the 8-mg, 16-mg, and 32-mg tablets as a colorant."
},
{
"NDCCode": "49884-660-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (49884-660-09) ",
"NDC11Code": "49884-0660-09",
"ProductNDC": "49884-660",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Candesartan Cilexetil",
"NonProprietaryName": "Candesartan Cilexetil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130521",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020838",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "CANDESARTAN CILEXETIL",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130521",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). , 2 Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2).",
"Description": "Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C33H34N6O6, and its structural formula is. Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Candesartan cilexetil is available for oral use as tablets containing either 4 mg, 8 mg, 16 mg, or 32 mg of candesartan cilexetil and the following inactive ingredients: hydroxypropyl cellulose, polyethylene glycol, lactose, corn starch, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide (reddish brown) is added to the 8-mg, 16-mg, and 32-mg tablets as a colorant."
},
{
"NDCCode": "49884-661-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (49884-661-09) ",
"NDC11Code": "49884-0661-09",
"ProductNDC": "49884-661",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Candesartan Cilexetil",
"NonProprietaryName": "Candesartan Cilexetil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130521",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020838",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "CANDESARTAN CILEXETIL",
"StrengthNumber": "32",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130521",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). , 2 Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2).",
"Description": "Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C33H34N6O6, and its structural formula is. Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Candesartan cilexetil is available for oral use as tablets containing either 4 mg, 8 mg, 16 mg, or 32 mg of candesartan cilexetil and the following inactive ingredients: hydroxypropyl cellulose, polyethylene glycol, lactose, corn starch, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide (reddish brown) is added to the 8-mg, 16-mg, and 32-mg tablets as a colorant."
},
{
"NDCCode": "0404-0375-47",
"PackageDescription": "144 PACKET in 1 CARTON (0404-0375-47) > 5 g in 1 PACKET (0404-0375-05) ",
"NDC11Code": "00404-0375-47",
"ProductNDC": "0404-0375",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "A And D",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111204",
"EndMarketingDate": "20240901",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "937.5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20111204",
"EndMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Temporarily protects minor: cuts, scrapes, burns. Temporarily protects and helps chapped or cracked skin and lips. Helps protect lips from drying effects of wind and cold weather."
},
{
"NDCCode": "10019-937-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (10019-937-01) / 100 mL in 1 VIAL, SINGLE-DOSE (10019-937-10) ",
"NDC11Code": "10019-0937-01",
"ProductNDC": "10019-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclophosphamide",
"NonProprietaryName": "Cyclophosphamide",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20080521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040745",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "CYCLOPHOSPHAMIDE",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080521",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclophosphamide is an alkylating drug indicated for treatment of: 1 Malignant Diseases: malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma (1.1), 2 Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy (1.2), 3 Limitations of Use:, 4 The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established.",
"Description": "Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide is a white crystalline powder with the molecular formula C7H15Cl2N2O2PH2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide for Injection, USP is a sterile white powder available as 500 mg, 1 g, and 2 g strength vials. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, 2 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, 3 2 g vial contains 2138.0 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide."
},
{
"NDCCode": "10544-937-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (10544-937-04)",
"NDC11Code": "10544-0937-04",
"ProductNDC": "10544-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201506",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Valacyclovir hydrochloride is a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients ( 1.1) : 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission , 3 Herpes Zoster .",
"Description": "Valacyclovir hydrochloride,USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pK as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "11673-937-48",
"PackageDescription": "258 g in 1 CAN (11673-937-48) ",
"NDC11Code": "11673-0937-48",
"ProductNDC": "11673-937",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up",
"ProprietaryNameSuffix": "Sport Sunscreen Broad Spectrum Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191009",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "TARGET CORPORATION",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 100; 50; 40; 50",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191009",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "13537-937-44",
"PackageDescription": "1 TUBE in 1 BOX (13537-937-44) > 4 g in 1 TUBE (13537-937-43)",
"NDC11Code": "13537-0937-44",
"ProductNDC": "13537-937",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25",
"ProprietaryNameSuffix": "(rosa Romantica Femme) - Pink",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140930",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".066; .015",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14593-937-01",
"PackageDescription": "15 kg in 1 DRUM (14593-937-01) ",
"NDC11Code": "14593-0937-01",
"ProductNDC": "14593-937",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Isosulfan Blue",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230925",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Emcure Pharmaceuticals Limited",
"SubstanceName": "ISOSULFAN BLUE",
"StrengthNumber": "15",
"StrengthUnit": "kg/15kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-06",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "25-SEP-23"
},
{
"NDCCode": "16590-937-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (16590-937-30)",
"NDC11Code": "16590-0937-30",
"ProductNDC": "16590-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ativan",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017794",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Ativan (lorazepam), an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Ativan (lorazepam) tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "16590-937-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (16590-937-60)",
"NDC11Code": "16590-0937-60",
"ProductNDC": "16590-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ativan",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017794",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Ativan (lorazepam), an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Ativan (lorazepam) tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "16590-937-72",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (16590-937-72)",
"NDC11Code": "16590-0937-72",
"ProductNDC": "16590-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ativan",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017794",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Ativan (lorazepam), an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Ativan (lorazepam) tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "16590-937-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (16590-937-90)",
"NDC11Code": "16590-0937-90",
"ProductNDC": "16590-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ativan",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017794",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Ativan (lorazepam), an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Ativan (lorazepam) tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "16714-937-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16714-937-01) ",
"NDC11Code": "16714-0937-01",
"ProductNDC": "16714-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol And Chlorthalidone",
"NonProprietaryName": "Atenolol And Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210028",
"LabelerName": "Northstar Rx LLC.",
"SubstanceName": "ATENOLOL; CHLORTHALIDONE",
"StrengthNumber": "100; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide-like Diuretic [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190326",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol and chlorthalidone tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol and chlorthalidone. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.",
"Description": "Atenolol and chlorthalidone tablets are for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking agent (atenolol) and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]. Atenolol, USP is a white or almost white powder and is sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether. Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl) benzene sulfonamide. Chlorthalidone, USP is white to yellowish crystalline powder. Each atenolol and chlorthalidone tablet, USP intended for oral administration contains atenolol 50 mg or 100 mg and chlorthalidone 25 mg. In addition, each uncoated tablet contains the following inactive ingredients: citric acid, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, pregelatinized starch and silicified microcrystalline cellulose."
},
{
"NDCCode": "17478-937-05",
"PackageDescription": "10 VIAL in 1 CARTON (17478-937-05) > 5 mL in 1 VIAL",
"NDC11Code": "17478-0937-05",
"ProductNDC": "17478-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075086",
"LabelerName": "Akorn",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20061221",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride injection is indicated for the following: : 1 Atrial Fibrillation or Atrial Flutter. Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. , 2 Paroxysmal Supraventricular Tachycardia. Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. .",
"Description": "Diltiazem hydrochloride injection is a calcium ion influx inhibitor (slow channel blocker or calcium channel antagonist). Chemically diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is:. The molecular formula is C22H26N2O4SHCl. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.99. Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. It has a pH range of 3.7 to 4.1. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. Each mL contains: Active: 5 mg Diltiazem Hydrochloride. Inactives: 0.75 mg Citric Acid USP, 0.65 mg Sodium Citrate Dihydrate USP, 71.4 mg Sorbitol Solution USP, and Water for Injection USP up to 1 mL, Sodium Hydroxide and/or Hydrochloric Acid are used for pH adjustment."
},
{
"NDCCode": "17478-937-10",
"PackageDescription": "10 VIAL in 1 CARTON (17478-937-10) > 10 mL in 1 VIAL",
"NDC11Code": "17478-0937-10",
"ProductNDC": "17478-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075086",
"LabelerName": "Akorn",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20061221",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride injection is indicated for the following: : 1 Atrial Fibrillation or Atrial Flutter. Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. , 2 Paroxysmal Supraventricular Tachycardia. Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. .",
"Description": "Diltiazem hydrochloride injection is a calcium ion influx inhibitor (slow channel blocker or calcium channel antagonist). Chemically diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is:. The molecular formula is C22H26N2O4SHCl. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.99. Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. It has a pH range of 3.7 to 4.1. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. Each mL contains: Active: 5 mg Diltiazem Hydrochloride. Inactives: 0.75 mg Citric Acid USP, 0.65 mg Sodium Citrate Dihydrate USP, 71.4 mg Sorbitol Solution USP, and Water for Injection USP up to 1 mL, Sodium Hydroxide and/or Hydrochloric Acid are used for pH adjustment."
},
{
"NDCCode": "17478-937-25",
"PackageDescription": "1 VIAL in 1 CARTON (17478-937-25) > 25 mL in 1 VIAL",
"NDC11Code": "17478-0937-25",
"ProductNDC": "17478-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075086",
"LabelerName": "Akorn",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20061221",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride injection is indicated for the following: : 1 Atrial Fibrillation or Atrial Flutter. Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. , 2 Paroxysmal Supraventricular Tachycardia. Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. .",
"Description": "Diltiazem hydrochloride injection is a calcium ion influx inhibitor (slow channel blocker or calcium channel antagonist). Chemically diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is:. The molecular formula is C22H26N2O4SHCl. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.99. Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. It has a pH range of 3.7 to 4.1. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. Each mL contains: Active: 5 mg Diltiazem Hydrochloride. Inactives: 0.75 mg Citric Acid USP, 0.65 mg Sodium Citrate Dihydrate USP, 71.4 mg Sorbitol Solution USP, and Water for Injection USP up to 1 mL, Sodium Hydroxide and/or Hydrochloric Acid are used for pH adjustment."
},
{
"NDCCode": "17478-937-26",
"PackageDescription": "10 VIAL in 1 CARTON (17478-937-26) > 25 mL in 1 VIAL",
"NDC11Code": "17478-0937-26",
"ProductNDC": "17478-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075086",
"LabelerName": "Akorn",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140815",
"SamplePackage": "N"
},
{
"NDCCode": "21130-937-91",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (21130-937-91) ",
"NDC11Code": "21130-0937-91",
"ProductNDC": "21130-937",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Daytime Severe Cold",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190517",
"EndMarketingDate": "20250301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Safeway",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "500; 20; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190517",
"EndMarketingDatePackage": "20250301",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. cough due to minor throat and bronchial irritation. temporarily reduces fever."
},
{
"NDCCode": "23155-937-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (23155-937-01) ",
"NDC11Code": "23155-0937-01",
"ProductNDC": "23155-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bethanechol Chloride",
"NonProprietaryName": "Bethanechol Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091256",
"LabelerName": "Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.",
"SubstanceName": "BETHANECHOL CHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.",
"Description": "Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N,-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN2O2 and its structural formula is. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: lactose monohydrate, silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and povidone."
},
{
"NDCCode": "24385-937-58",
"PackageDescription": "1 BOTTLE in 1 CARTON (24385-937-58) > 40 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "24385-0937-58",
"ProductNDC": "24385-937",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Ibuprofen Pm",
"NonProprietaryName": "Diphenhydramine Citrate, Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090223",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079113",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
"StrengthNumber": "38; 200",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090223",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "24385-937-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (24385-937-60) > 20 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "24385-0937-60",
"ProductNDC": "24385-937",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Ibuprofen Pm",
"NonProprietaryName": "Diphenhydramine Citrate, Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090223",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079113",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
"StrengthNumber": "38; 200",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090309",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "24470-937-06",
"PackageDescription": "177 mL in 1 BOTTLE, PLASTIC (24470-937-06) ",
"NDC11Code": "24470-0937-06",
"ProductNDC": "24470-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfacetamide Sodium",
"NonProprietaryName": "Sulfacetamide Sodium",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240904",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Cintex Services, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2024-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240904",
"SamplePackage": "N",
"IndicationAndUsage": "This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.",
"Description": "Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: citric acid, disodium EDTA, fragrance, methylparaben, PEG-150 pentaerythrityl tetrastearate (and) aqua (and) PEG-6 caprylic/capric glycerides, PEG-60 almond glycerides, propylene glycol, propylparaben, purified water, sodium chloride, and sodium laureth sulfate (and) cocamide DEA (and) cocamidopropyl betaine (and) glycol stearate. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "30142-937-56",
"PackageDescription": "226 g in 1 BOTTLE, PLASTIC (30142-937-56)",
"NDC11Code": "30142-0937-56",
"ProductNDC": "30142-937",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kroger Sport Sunscreen",
"ProprietaryNameSuffix": "Spf 50",
"NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140627",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "THE KROGER CO",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 13; 5; 5; 6",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "35000-937-02",
"PackageDescription": "1 TUBE in 1 CARTON (35000-937-02) / 56.6 g in 1 TUBE",
"NDC11Code": "35000-0937-02",
"ProductNDC": "35000-937",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Optic White Stain Fighter Clean Mint",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20171130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "COLGATE PALMOLIVE COMPANY",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171130",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>49884-937-67</NDCCode>
<PackageDescription>210 g in 1 CAN (49884-937-67) </PackageDescription>
<NDC11Code>49884-0937-67</NDC11Code>
<ProductNDC>49884-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Questran</ProprietaryName>
<NonProprietaryName>Cholestyramine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077203</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>CHOLESTYRAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/5g</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1) QUESTRAN (Cholestyramine for Oral Suspension USP), is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. QUESTRAN may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with QUESTRAN secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess Total cholesterol, HDL-C, and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total cholesterol – [(TG/5) + HDL-C]. For TG levels >400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases QUESTRAN may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of QUESTRAN therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of QUESTRAN or adding other lipid-lowering agents in combination with QUESTRAN should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. QUESTRAN monotherapy has been demonstrated to retard the rate of progression 2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) QUESTRAN is indicated for the relief of pruritus associated with partial biliary obstruction. QUESTRAN has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.</IndicationAndUsage>
<Description>QUESTRAN ® (Cholestyramine for Oral Suspension USP), the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in QUESTRAN is not absorbed from the digestive tract. Four grams of anhydrous cholestyramine resin is contained in 9 grams of QUESTRAN powder. Four grams of anhydrous cholestyramine resin is contained in 5 grams of QUESTRAN LIGHT. It is represented by the following structural formula. QUESTRAN powder contains the following inactive ingredients: acacia, citric acid, D&C Yellow No. 10, FD&C Yellow No.6, flavor (natural and artificial Orange), polysorbate 80, propylene glycol alginate and sucrose. QUESTRAN LIGHT contains the following inactive ingredients: aspartame, citric acid, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Red No.40, flavor (natural and artificial Orange), maltodextrin, propylene glycol alginate and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>49884-937-65</NDCCode>
<PackageDescription>60 PACKET in 1 CARTON (49884-937-65) > 5 g in 1 PACKET (49884-937-63)</PackageDescription>
<NDC11Code>49884-0937-65</NDC11Code>
<ProductNDC>49884-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Questran</ProprietaryName>
<NonProprietaryName>Cholestyramine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077203</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>CHOLESTYRAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/5g</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49884-466-67</NDCCode>
<PackageDescription>210 g in 1 CAN (49884-466-67) </PackageDescription>
<NDC11Code>49884-0466-67</NDC11Code>
<ProductNDC>49884-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cholestyramine</ProprietaryName>
<NonProprietaryName>Cholestyramine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077203</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>CHOLESTYRAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/5g</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1) Cholestyramine for Oral Suspension USP is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with Cholestyramine, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess Total cholesterol, HDL-C, and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total cholesterol – [(TG/5) + HDL-C]. For TG levels >400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases Cholestyramine may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of Cholestyramine therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of Cholestyramine or adding other lipid-lowering agents in combination with Cholestyramine should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. Cholestyramine monotherapy has been demonstrated to retard the rate of progression 2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) Cholestyramine for oral suspension is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine for oral suspension has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.</IndicationAndUsage>
<Description>Cholestyramine for Oral Suspension USP, the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in Cholestyramine is not absorbed from the digestive tract. Four grams of anhydrous cholestyramine resin is contained in 9 grams of Cholestyramine for Oral Suspension USP. Four grams of anhydrous cholestyramine resin is contained in 5 grams of Cholestyramine for Oral Suspension USP, Light. It is represented by the following structural formula. Cholestyramine for Oral Suspension USP contains the following inactive ingredients: acacia, citric acid, D&C Yellow No. 10, FD&C Yellow No. 6, flavor (natural and artificial Orange), polysorbate 80, propylene glycol alginate and sucrose. Cholestyramine for Oral Suspension USP, Light contains the following inactive ingredients: aspartame, citric acid, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Red No. 40, flavor (natural and artificial Orange), maltodextrin, propylene glycol alginate and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>49884-264-95</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49884-264-95) / 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>49884-0264-95</NDC11Code>
<ProductNDC>49884-264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycerol Phenylbutyrate</ProprietaryName>
<NonProprietaryName>Glycerol Phenylbutyrate Oral</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205742</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>GLYCEROL PHENYLBUTYRATE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycerol phenylbutyrate oral liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Glycerol phenylbutyrate oral liquid must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements). Limitations of Use: : 1 Glycerol phenylbutyrate oral liquid is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels. , 2 The safety and efficacy of glycerol phenylbutyrate oral liquid for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established. .</IndicationAndUsage>
<Description>Glycerol phenylbutyrate is a clear, colorless to pale yellow oral liquid. It is soluble in dimethylsulfoxide (DMSO) and in dimethyl formamide. Glycerol phenylbutyrate is a nitrogen-binding agent. It is a triglyceride containing 3 molecules of PBA linked to a glycerol backbone, the chemical name of which is benzenebutanoic acid, 1', 1' ' –(1,2,3-propanetriyl) ester with a molecular weight of 530.67. It has a molecular formula of C33H38O6. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>49884-658-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (49884-658-09) </PackageDescription>
<NDC11Code>49884-0658-09</NDC11Code>
<ProductNDC>49884-658</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Candesartan Cilexetil</ProprietaryName>
<NonProprietaryName>Candesartan Cilexetil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130521</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020838</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>CANDESARTAN CILEXETIL</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130521</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). , 2 Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2).</IndicationAndUsage>
<Description>Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C33H34N6O6, and its structural formula is. Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Candesartan cilexetil is available for oral use as tablets containing either 4 mg, 8 mg, 16 mg, or 32 mg of candesartan cilexetil and the following inactive ingredients: hydroxypropyl cellulose, polyethylene glycol, lactose, corn starch, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide (reddish brown) is added to the 8-mg, 16-mg, and 32-mg tablets as a colorant.</Description>
</NDC>
<NDC>
<NDCCode>49884-659-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (49884-659-09) </PackageDescription>
<NDC11Code>49884-0659-09</NDC11Code>
<ProductNDC>49884-659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Candesartan Cilexetil</ProprietaryName>
<NonProprietaryName>Candesartan Cilexetil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130521</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020838</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>CANDESARTAN CILEXETIL</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130521</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). , 2 Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2).</IndicationAndUsage>
<Description>Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C33H34N6O6, and its structural formula is. Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Candesartan cilexetil is available for oral use as tablets containing either 4 mg, 8 mg, 16 mg, or 32 mg of candesartan cilexetil and the following inactive ingredients: hydroxypropyl cellulose, polyethylene glycol, lactose, corn starch, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide (reddish brown) is added to the 8-mg, 16-mg, and 32-mg tablets as a colorant.</Description>
</NDC>
<NDC>
<NDCCode>49884-660-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (49884-660-09) </PackageDescription>
<NDC11Code>49884-0660-09</NDC11Code>
<ProductNDC>49884-660</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Candesartan Cilexetil</ProprietaryName>
<NonProprietaryName>Candesartan Cilexetil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130521</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020838</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>CANDESARTAN CILEXETIL</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130521</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). , 2 Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2).</IndicationAndUsage>
<Description>Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C33H34N6O6, and its structural formula is. Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Candesartan cilexetil is available for oral use as tablets containing either 4 mg, 8 mg, 16 mg, or 32 mg of candesartan cilexetil and the following inactive ingredients: hydroxypropyl cellulose, polyethylene glycol, lactose, corn starch, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide (reddish brown) is added to the 8-mg, 16-mg, and 32-mg tablets as a colorant.</Description>
</NDC>
<NDC>
<NDCCode>49884-661-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (49884-661-09) </PackageDescription>
<NDC11Code>49884-0661-09</NDC11Code>
<ProductNDC>49884-661</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Candesartan Cilexetil</ProprietaryName>
<NonProprietaryName>Candesartan Cilexetil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130521</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020838</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>CANDESARTAN CILEXETIL</SubstanceName>
<StrengthNumber>32</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130521</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). , 2 Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2).</IndicationAndUsage>
<Description>Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C33H34N6O6, and its structural formula is. Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Candesartan cilexetil is available for oral use as tablets containing either 4 mg, 8 mg, 16 mg, or 32 mg of candesartan cilexetil and the following inactive ingredients: hydroxypropyl cellulose, polyethylene glycol, lactose, corn starch, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide (reddish brown) is added to the 8-mg, 16-mg, and 32-mg tablets as a colorant.</Description>
</NDC>
<NDC>
<NDCCode>0404-0375-47</NDCCode>
<PackageDescription>144 PACKET in 1 CARTON (0404-0375-47) > 5 g in 1 PACKET (0404-0375-05) </PackageDescription>
<NDC11Code>00404-0375-47</NDC11Code>
<ProductNDC>0404-0375</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>A And D</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111204</StartMarketingDate>
<EndMarketingDate>20240901</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>937.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20111204</StartMarketingDatePackage>
<EndMarketingDatePackage>20240901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Temporarily protects minor: cuts, scrapes, burns. Temporarily protects and helps chapped or cracked skin and lips. Helps protect lips from drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10019-937-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (10019-937-01) / 100 mL in 1 VIAL, SINGLE-DOSE (10019-937-10) </PackageDescription>
<NDC11Code>10019-0937-01</NDC11Code>
<ProductNDC>10019-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclophosphamide</ProprietaryName>
<NonProprietaryName>Cyclophosphamide</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20080521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040745</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>CYCLOPHOSPHAMIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclophosphamide is an alkylating drug indicated for treatment of: 1 Malignant Diseases: malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma (1.1), 2 Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy (1.2), 3 Limitations of Use:, 4 The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established.</IndicationAndUsage>
<Description>Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide is a white crystalline powder with the molecular formula C7H15Cl2N2O2PH2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide for Injection, USP is a sterile white powder available as 500 mg, 1 g, and 2 g strength vials. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, 2 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, 3 2 g vial contains 2138.0 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide.</Description>
</NDC>
<NDC>
<NDCCode>10544-937-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (10544-937-04)</PackageDescription>
<NDC11Code>10544-0937-04</NDC11Code>
<ProductNDC>10544-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201506</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Valacyclovir hydrochloride is a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients ( 1.1) : 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission , 3 Herpes Zoster .</IndicationAndUsage>
<Description>Valacyclovir hydrochloride,USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pK as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>11673-937-48</NDCCode>
<PackageDescription>258 g in 1 CAN (11673-937-48) </PackageDescription>
<NDC11Code>11673-0937-48</NDC11Code>
<ProductNDC>11673-937</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up</ProprietaryName>
<ProprietaryNameSuffix>Sport Sunscreen Broad Spectrum Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191009</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>TARGET CORPORATION</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 100; 50; 40; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-937-44</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-937-44) > 4 g in 1 TUBE (13537-937-43)</PackageDescription>
<NDC11Code>13537-0937-44</NDC11Code>
<ProductNDC>13537-937</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(rosa Romantica Femme) - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140930</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.066; .015</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14593-937-01</NDCCode>
<PackageDescription>15 kg in 1 DRUM (14593-937-01) </PackageDescription>
<NDC11Code>14593-0937-01</NDC11Code>
<ProductNDC>14593-937</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Isosulfan Blue</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230925</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
<SubstanceName>ISOSULFAN BLUE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>kg/15kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-06</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-SEP-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>16590-937-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (16590-937-30)</PackageDescription>
<NDC11Code>16590-0937-30</NDC11Code>
<ProductNDC>16590-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ativan</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017794</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Ativan (lorazepam), an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Ativan (lorazepam) tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>16590-937-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (16590-937-60)</PackageDescription>
<NDC11Code>16590-0937-60</NDC11Code>
<ProductNDC>16590-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ativan</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017794</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Ativan (lorazepam), an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Ativan (lorazepam) tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>16590-937-72</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (16590-937-72)</PackageDescription>
<NDC11Code>16590-0937-72</NDC11Code>
<ProductNDC>16590-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ativan</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017794</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Ativan (lorazepam), an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Ativan (lorazepam) tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>16590-937-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (16590-937-90)</PackageDescription>
<NDC11Code>16590-0937-90</NDC11Code>
<ProductNDC>16590-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ativan</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017794</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Ativan (lorazepam), an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Ativan (lorazepam) tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>16714-937-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16714-937-01) </PackageDescription>
<NDC11Code>16714-0937-01</NDC11Code>
<ProductNDC>16714-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol And Chlorthalidone</ProprietaryName>
<NonProprietaryName>Atenolol And Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210028</ApplicationNumber>
<LabelerName>Northstar Rx LLC.</LabelerName>
<SubstanceName>ATENOLOL; CHLORTHALIDONE</SubstanceName>
<StrengthNumber>100; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide-like Diuretic [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol and chlorthalidone tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol and chlorthalidone. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.</IndicationAndUsage>
<Description>Atenolol and chlorthalidone tablets are for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking agent (atenolol) and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]. Atenolol, USP is a white or almost white powder and is sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether. Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl) benzene sulfonamide. Chlorthalidone, USP is white to yellowish crystalline powder. Each atenolol and chlorthalidone tablet, USP intended for oral administration contains atenolol 50 mg or 100 mg and chlorthalidone 25 mg. In addition, each uncoated tablet contains the following inactive ingredients: citric acid, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, pregelatinized starch and silicified microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>17478-937-05</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (17478-937-05) > 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>17478-0937-05</NDC11Code>
<ProductNDC>17478-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075086</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride injection is indicated for the following: : 1 Atrial Fibrillation or Atrial Flutter. Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. , 2 Paroxysmal Supraventricular Tachycardia. Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. .</IndicationAndUsage>
<Description>Diltiazem hydrochloride injection is a calcium ion influx inhibitor (slow channel blocker or calcium channel antagonist). Chemically diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is:. The molecular formula is C22H26N2O4SHCl. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.99. Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. It has a pH range of 3.7 to 4.1. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. Each mL contains: Active: 5 mg Diltiazem Hydrochloride. Inactives: 0.75 mg Citric Acid USP, 0.65 mg Sodium Citrate Dihydrate USP, 71.4 mg Sorbitol Solution USP, and Water for Injection USP up to 1 mL, Sodium Hydroxide and/or Hydrochloric Acid are used for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>17478-937-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (17478-937-10) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>17478-0937-10</NDC11Code>
<ProductNDC>17478-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075086</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride injection is indicated for the following: : 1 Atrial Fibrillation or Atrial Flutter. Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. , 2 Paroxysmal Supraventricular Tachycardia. Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. .</IndicationAndUsage>
<Description>Diltiazem hydrochloride injection is a calcium ion influx inhibitor (slow channel blocker or calcium channel antagonist). Chemically diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is:. The molecular formula is C22H26N2O4SHCl. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.99. Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. It has a pH range of 3.7 to 4.1. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. Each mL contains: Active: 5 mg Diltiazem Hydrochloride. Inactives: 0.75 mg Citric Acid USP, 0.65 mg Sodium Citrate Dihydrate USP, 71.4 mg Sorbitol Solution USP, and Water for Injection USP up to 1 mL, Sodium Hydroxide and/or Hydrochloric Acid are used for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>17478-937-25</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (17478-937-25) > 25 mL in 1 VIAL</PackageDescription>
<NDC11Code>17478-0937-25</NDC11Code>
<ProductNDC>17478-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075086</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride injection is indicated for the following: : 1 Atrial Fibrillation or Atrial Flutter. Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. , 2 Paroxysmal Supraventricular Tachycardia. Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. .</IndicationAndUsage>
<Description>Diltiazem hydrochloride injection is a calcium ion influx inhibitor (slow channel blocker or calcium channel antagonist). Chemically diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is:. The molecular formula is C22H26N2O4SHCl. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.99. Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. It has a pH range of 3.7 to 4.1. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. Each mL contains: Active: 5 mg Diltiazem Hydrochloride. Inactives: 0.75 mg Citric Acid USP, 0.65 mg Sodium Citrate Dihydrate USP, 71.4 mg Sorbitol Solution USP, and Water for Injection USP up to 1 mL, Sodium Hydroxide and/or Hydrochloric Acid are used for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>17478-937-26</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (17478-937-26) > 25 mL in 1 VIAL</PackageDescription>
<NDC11Code>17478-0937-26</NDC11Code>
<ProductNDC>17478-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075086</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>21130-937-91</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (21130-937-91) </PackageDescription>
<NDC11Code>21130-0937-91</NDC11Code>
<ProductNDC>21130-937</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Daytime Severe Cold</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190517</StartMarketingDate>
<EndMarketingDate>20250301</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 20; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190517</StartMarketingDatePackage>
<EndMarketingDatePackage>20250301</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. cough due to minor throat and bronchial irritation. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23155-937-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (23155-937-01) </PackageDescription>
<NDC11Code>23155-0937-01</NDC11Code>
<ProductNDC>23155-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bethanechol Chloride</ProprietaryName>
<NonProprietaryName>Bethanechol Chloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091256</ApplicationNumber>
<LabelerName>Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.</LabelerName>
<SubstanceName>BETHANECHOL CHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.</IndicationAndUsage>
<Description>Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N,-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN2O2 and its structural formula is. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: lactose monohydrate, silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>24385-937-58</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (24385-937-58) > 40 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>24385-0937-58</NDC11Code>
<ProductNDC>24385-937</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy Ibuprofen Pm</ProprietaryName>
<NonProprietaryName>Diphenhydramine Citrate, Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090223</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079113</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>DIPHENHYDRAMINE CITRATE; IBUPROFEN</SubstanceName>
<StrengthNumber>38; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090223</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24385-937-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (24385-937-60) > 20 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>24385-0937-60</NDC11Code>
<ProductNDC>24385-937</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy Ibuprofen Pm</ProprietaryName>
<NonProprietaryName>Diphenhydramine Citrate, Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090223</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079113</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>DIPHENHYDRAMINE CITRATE; IBUPROFEN</SubstanceName>
<StrengthNumber>38; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090309</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24470-937-06</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE, PLASTIC (24470-937-06) </PackageDescription>
<NDC11Code>24470-0937-06</NDC11Code>
<ProductNDC>24470-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfacetamide Sodium</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240904</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Cintex Services, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.</IndicationAndUsage>
<Description>Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: citric acid, disodium EDTA, fragrance, methylparaben, PEG-150 pentaerythrityl tetrastearate (and) aqua (and) PEG-6 caprylic/capric glycerides, PEG-60 almond glycerides, propylene glycol, propylparaben, purified water, sodium chloride, and sodium laureth sulfate (and) cocamide DEA (and) cocamidopropyl betaine (and) glycol stearate. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>30142-937-56</NDCCode>
<PackageDescription>226 g in 1 BOTTLE, PLASTIC (30142-937-56)</PackageDescription>
<NDC11Code>30142-0937-56</NDC11Code>
<ProductNDC>30142-937</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kroger Sport Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140627</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>THE KROGER CO</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3; 13; 5; 5; 6</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-937-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-937-02) / 56.6 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0937-02</NDC11Code>
<ProductNDC>35000-937</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate Optic White Stain Fighter Clean Mint</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20171130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>COLGATE PALMOLIVE COMPANY</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
</NDC>
</NDCList>