{
"NDC": [
{
"NDCCode": "51224-426-10",
"PackageDescription": "112 TABLET in 1 BOTTLE (51224-426-10) ",
"NDC11Code": "51224-0426-10",
"ProductNDC": "51224-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetrabenazine",
"NonProprietaryName": "Tetrabenazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170201",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207682",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "TETRABENAZINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170201",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Tetrabenazine tablet is indicated for the treatment of chorea associated with Huntington's disease.",
"Description": "TETRABENAZINE is a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.43; the pKa is 6 .51. Tetrabenazine is a hexahydro-dimethoxy-benzoquinolizine derivative and has the following chemical name: cis rac –1, 3, 4, 6, 7, 11b-hexahydro-9, 10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one.The empirical formula C19H27NO3 is represented by the following structural formula. Tetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol. Each Tetrabenazine tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient. Tetrabenazine tablet contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose, magnesium stearate, maize starch, and talc. The 25 mg strength tablet also contains yellow iron oxide as an inactive ingredient. Tetrabenazine tablet is supplied as a yellowish-buff scored tablet containing 25 mg of TETRABENAZINE or as a white non-scored tablet containing 12.5 mg of TETRABENAZINE."
},
{
"NDCCode": "51224-009-10",
"PackageDescription": "201.6 g in 1 CAN (51224-009-10) ",
"NDC11Code": "51224-0009-10",
"ProductNDC": "51224-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cholestyramine Light",
"NonProprietaryName": "Cholestyramine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20201112",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209599",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "CHOLESTYRAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/4.8g",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201112",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "1) Cholestyramine for oral suspension USP, light 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 for oral suspension USP, light 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 resin, 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 resin 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 resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP4 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 resin monotherapy has been demonstrated to retard the rate of progression2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) Cholestyramine for oral suspension USP, light is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin 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, light, 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. Cholestyramine resin is not absorbed from the digestive tract. Each 4.8 grams of cholestyramine for oral suspension USP, light contain 4 grams of cholestyramine resin. It is represented by the following structural formula. Inactive Ingredients: aspartame, citric acid anhydrous, colloidal silicon dioxide, propylene glycol alginate, xanthan gum, natural orange flavor, D&C yellow No. 10 aluminum lake and FD&C yellow No. 6 aluminum lake."
},
{
"NDCCode": "51224-011-10",
"PackageDescription": "348.6 g in 1 CAN (51224-011-10) ",
"NDC11Code": "51224-0011-10",
"ProductNDC": "51224-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cholestyramine",
"NonProprietaryName": "Cholestyramine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210310",
"EndMarketingDate": "20261130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209597",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "CHOLESTYRAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/8.3g",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210310",
"EndMarketingDatePackage": "20261130",
"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 for Oral Suspension, USP 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 resin, 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 resin, 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 resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP4 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 resin monotherapy has been demonstrated to retard the rate of progression2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) Cholestyramine for Oral Suspension, USP is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin 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. Cholestyramine resin is not absorbed from the digestive tract. 8.3 grams of Cholestyramine for Oral Suspension, USP contain 4 grams of cholestyramine resin. It is represented by the following structural formula. Inactive ingredients: sucrose (429.5 mg/g), propylene glycol alginate, natural orange flavor, anhydrous citric acid, D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6 aluminum lake."
},
{
"NDCCode": "51224-012-10",
"PackageDescription": "10 CARTON in 1 TRAY (51224-012-10) / 1 VIAL in 1 CARTON (51224-012-20) / 1 INJECTION in 1 VIAL",
"NDC11Code": "51224-0012-10",
"ProductNDC": "51224-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentolamine Mesylate",
"NonProprietaryName": "Phentolamine Mesylate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20170715",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207686",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "PHENTOLAMINE MESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170715",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "Phentolamine Mesylate for Injection, USP is indicated for the prevention or control of hypertensive episodes that may occur in a patient with pheochromocytoma as a result of stress or manipulation during preoperative preparation and surgical excision. Phentolamine Mesylate for Injection, USP is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine. Phentolamine Mesylate for Injection, USP is also indicated for the diagnosis of pheochromocytoma by the Phentolamine Mesylate for Injection, USP blocking test.",
"Description": "Phentolamine Mesylate for Injection, USP is an antihypertensive, available in vials for intravenous and intramuscular administration. Each vial contains phentolamine mesylate, USP, 5 mg, and mannitol USP, 25 mg, in sterile, lyophilized form. Phentolamine Mesylate, USP is 4,5-dihydro-2-[N-(m-hydroxyphenyl)-N-(p-methylphenyl) aminomethyl]-1H-imidazole 1:1 methanesulfonate, and its structural formula is. Phentolamine mesylate, USP is a white or off-white, odorless crystalline powder with a molecular weight of 377.46. Its solutions are acid to litmus. It is freely soluble in water and in alcohol, and slightly soluble in chloroform. It melts at about 178°C."
},
{
"NDCCode": "51224-013-10",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (51224-013-10) / 5 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "51224-0013-10",
"ProductNDC": "51224-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209781",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181130",
"EndMarketingDatePackage": "20260810",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) . Levetiracetam injection is indicated for adjunctive therapy for the treatment of:. Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) . Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) . Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible ( 1.4) .",
"Description": "Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection contains 100 mg of levetiracetam per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [ see Dosage and Administration ( 2.6) ]."
},
{
"NDCCode": "51224-015-10",
"PackageDescription": "10 VIAL in 1 CARTON (51224-015-10) > 20 mL in 1 VIAL (51224-015-01) ",
"NDC11Code": "51224-0015-10",
"ProductNDC": "51224-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride In Sodium Chloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212857",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201123",
"SamplePackage": "N"
},
{
"NDCCode": "51224-215-10",
"PackageDescription": "10 BOTTLE in 1 CARTON (51224-215-10) > 100 mL in 1 BOTTLE (51224-215-01) ",
"NDC11Code": "51224-0215-10",
"ProductNDC": "51224-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride In Sodium Chloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212857",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201123",
"SamplePackage": "N"
},
{
"NDCCode": "51224-300-10",
"PackageDescription": "500 mL in 1 BOTTLE (51224-300-10)",
"NDC11Code": "51224-0300-10",
"ProductNDC": "51224-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Codeine Sulfate",
"NonProprietaryName": "Codeine Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202245",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "CODEINE SULFATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2015-01-16"
},
{
"NDCCode": "51224-301-10",
"PackageDescription": "4 BOTTLE, UNIT-DOSE in 1 CARTON (51224-301-10) > 75 mL in 1 BOTTLE, UNIT-DOSE",
"NDC11Code": "51224-0301-10",
"ProductNDC": "51224-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20130225",
"EndMarketingDate": "20220430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090520",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/75mL",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130225",
"EndMarketingDatePackage": "20220430",
"SamplePackage": "N"
},
{
"NDCCode": "51224-400-10",
"PackageDescription": "1 CAN in 1 CARTON (51224-400-10) > 100 g in 1 CAN",
"NDC11Code": "51224-0400-10",
"ProductNDC": "51224-400",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benzoyl Peroxide Emollient",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131011",
"EndMarketingDate": "20200831",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "TAGI Pharma Inc.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "53",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131011",
"EndMarketingDatePackage": "20200831",
"SamplePackage": "N"
},
{
"NDCCode": "51224-401-10",
"PackageDescription": "1 CAN in 1 CARTON (51224-401-10) > 100 g in 1 CAN",
"NDC11Code": "51224-0401-10",
"ProductNDC": "51224-401",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benzoyl Peroxide Emollient",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131011",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "TAGI Pharma Inc.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "98",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-02-29",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "51224-425-10",
"PackageDescription": "112 TABLET in 1 BOTTLE (51224-425-10) ",
"NDC11Code": "51224-0425-10",
"ProductNDC": "51224-425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetrabenazine",
"NonProprietaryName": "Tetrabenazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170201",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207682",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "TETRABENAZINE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170201",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Tetrabenazine tablet is indicated for the treatment of chorea associated with Huntington's disease.",
"Description": "TETRABENAZINE is a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.43; the pKa is 6 .51. Tetrabenazine is a hexahydro-dimethoxy-benzoquinolizine derivative and has the following chemical name: cis rac –1, 3, 4, 6, 7, 11b-hexahydro-9, 10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one.The empirical formula C19H27NO3 is represented by the following structural formula. Tetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol. Each Tetrabenazine tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient. Tetrabenazine tablet contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose, magnesium stearate, maize starch, and talc. The 25 mg strength tablet also contains yellow iron oxide as an inactive ingredient. Tetrabenazine tablet is supplied as a yellowish-buff scored tablet containing 25 mg of TETRABENAZINE or as a white non-scored tablet containing 12.5 mg of TETRABENAZINE."
},
{
"NDCCode": "31722-426-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-426-10) ",
"NDC11Code": "31722-0426-10",
"ProductNDC": "31722-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214344",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240425",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.597 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending."
},
{
"NDCCode": "33342-426-10",
"PackageDescription": "90 TABLET in 1 BOTTLE (33342-426-10) ",
"NDC11Code": "33342-0426-10",
"ProductNDC": "33342-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorthalidone",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212229",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "CHLORTHALIDONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.",
"Description": "Chlorthalidone is an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1-hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, stearic acid. The 50 mg tablets also contain FD&C Blue No.1 Aluminum Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42494-426-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (42494-426-10) ",
"NDC11Code": "42494-0426-10",
"ProductNDC": "42494-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorzoxazone",
"NonProprietaryName": "Chlorzoxazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212254",
"LabelerName": "Cameron Pharmaceuticals",
"SubstanceName": "CHLORZOXAZONE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20191127",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.",
"Description": "Chlorzoxazone USP is a centrally acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. Its chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is. C7H4CINO2MW 169.57. Chlorzoxazone USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. Chlorzoxazone tablets contain the inactive ingredients Pregelatinized Starch, Croscarmellose Sodium, Microcrystalline Cellulose, Docusate Sodium, Sodium Benzoate, Colloidal Silicon dioxide, Magnesium Stearate."
},
{
"NDCCode": "43063-426-10",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (43063-426-10) ",
"NDC11Code": "43063-0426-10",
"ProductNDC": "43063-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040256",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130513",
"SamplePackage": "N"
},
{
"NDCCode": "43602-426-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (43602-426-10) ",
"NDC11Code": "43602-0426-10",
"ProductNDC": "43602-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215259",
"LabelerName": "Ascent Pharmaceuticals, Inc",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".175",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230118",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine sodium tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxyanisole, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate and color additive(s). Table 6 provides a listing of the color additives by tablet strength. FDA approved Dissolution test differs from the USP dissolution test. FDA approved Assay test differs from the USP assay test."
},
{
"NDCCode": "49281-426-50",
"PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-426-50) / .5 mg in 1 SYRINGE, GLASS (49281-426-88) ",
"NDC11Code": "49281-0426-50",
"ProductNDC": "49281-426",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluzone Trivalent Northern Hemisphere",
"NonProprietaryName": "Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/michigan/105/2025 San-049a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/tokyo/eis13-175/2025 Antigen (formaldehyde Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240702",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103914",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "15; 15; 15",
"StrengthUnit": "ug/.5mg; ug/.5mg; ug/.5mg",
"Status": "Active",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240702",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "Fluzone® is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.",
"Description": "Fluzone (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone. No presentation of Fluzone is made with natural rubber latex. Fluzone is formulated to contain HA of each of the following three influenza strains recommended for the 2026-2027 influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Michigan/105/2025 SAN-049A (A/Darwin/1454/2025-like virus) (H3N2), and B/Tokyo/EIS13-175/2025 (B Victoria lineage). These three influenza virus strains are recommended by FDA for the 2026-2027 influenza season. The amounts of HA and other ingredients per dose of vaccine are listed in Table 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multiple-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multiple-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multiple-dose vial contains 12.5 mcg mercury."
},
{
"NDCCode": "51013-426-48",
"PackageDescription": "1 BOTTLE in 1 CARTON (51013-426-48) > 10 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "51013-0426-48",
"ProductNDC": "51013-426",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20180212",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180212",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "52685-426-21",
"PackageDescription": "1 CONTAINER in 1 CARTON (52685-426-21) > 10 g in 1 CONTAINER",
"NDC11Code": "52685-0426-21",
"ProductNDC": "52685-426",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido The Makeup Foundation",
"ProprietaryNameSuffix": "B20",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20010101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "410",
"StrengthUnit": "mg/10g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54575-426-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-426-10)",
"NDC11Code": "54575-0426-10",
"ProductNDC": "54575-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Papaya",
"NonProprietaryName": "Papaya",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "PAPAYA",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
},
{
"NDCCode": "55150-426-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-426-10) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-426-01) ",
"NDC11Code": "55150-0426-10",
"ProductNDC": "55150-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216552",
"LabelerName": "Eugia US LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230329",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride injection is indicated for the following:Atrial Fibrillation or Atrial FlutterTemporary 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.Paroxysmal Supraventricular TachycardiaRapid 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.The use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium.For either indication and particularly when employing continuous intravenous infusion, the setting should include continuous monitoring of the ECG and frequent measurement of blood pressure. A defibrillator and emergency equipment should be readily available.In domestic controlled trials in patients with atrial fibrillation or atrial flutter, bolus administration of diltiazem hydrochloride injection was effective in reducing heart rate by at least 20% in 95% of patients. Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. Following administration of one or two intravenous bolus doses of diltiazem hydrochloride injection, response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes. Heart rate reduction may last from 1 to 3 hours. If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours.A 24 hour continuous infusion of diltiazem hydrochloride injection in the treatment of atrial fibrillation or atrial flutter maintained at least a 20% heart rate reduction during the infusion in 83% of patients. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). Hypotension, if it occurs, may be similarly persistent.In the controlled clinical trials, 3.2% of patients required some form of intervention (typically, use of intravenous fluids or the Trendelenburg position) for blood pressure support following diltiazem hydrochloride injection.In domestic controlled trials, bolus administration of diltiazem hydrochloride injection was effective in converting PSVT to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose.Symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular 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 chemical structure is. Diltiazem hydrochloride, USP is a white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 451.0. 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. 25-mg, 5-mL vial–each sterile vial contains 25 mg diltiazem hydrochloride, 3.75 mg citric acid USP, 3.25 mg sodium citrate dihydrate USP, 357 mg sorbitol solution USP, and water for injection USP up to 5 mL. Sodium hydroxide or hydrochloric acid is used for pH adjustment. 50-mg, 10-mL vial–each sterile vial contains 50 mg diltiazem hydrochloride, 7.5 mg citric acid USP, 6.5 mg sodium citrate dihydrate USP, 714 mg sorbitol solution USP, and water for injection USP up to 10 mL. Sodium hydroxide or hydrochloric acid is used for pH adjustment. 125-mg, 25-mL vial–each sterile vial contains 125 mg diltiazem hydrochloride, 18.75 mg citric acid USP, 16.25 mg sodium citrate dihydrate USP, 1,785 mg sorbitol solution USP, and water for injection USP up to 25 mL. Sodium hydroxide or hydrochloric acid is used for pH adjustment."
},
{
"NDCCode": "61703-434-82",
"PackageDescription": "10 KIT in 1 PACKAGE (61703-434-82) > 1 KIT in 1 KIT (61703-434-01) * 5 mL in 1 VIAL, SINGLE-DOSE (61703-426-02) * 5 mL in 1 VIAL, SINGLE-DOSE (61703-430-02) ",
"NDC11Code": "61703-0434-82",
"ProductNDC": "61703-434",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "M.v.i. Adult",
"NonProprietaryName": "Retinol, Ergocalciferol, .alpha.-tocopherol Acetate, Dl-, Phytonadione, Ascorbic Acid, Niacinamide, Riboflavin 5-phosphate Sodium, Thiamine Hydrochloride, Pyridoxine Hydrochloride, Dexpanthenol, Biotin, Folic Acid, And Cyanocobalamin",
"DosageFormName": "KIT",
"StartMarketingDate": "20170428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021625",
"LabelerName": "Hospira, Inc.",
"Status": "Deprecated",
"LastUpdate": "2021-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170428",
"SamplePackage": "N"
},
{
"NDCCode": "61919-426-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (61919-426-10) ",
"NDC11Code": "61919-0426-10",
"ProductNDC": "61919-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202801",
"LabelerName": "DIRECT RX",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190424",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. 1.1 Nosocomial Pneumonia. Levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen. Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae[see Dosage and Administration (2.1) and Clinical Studies (14.2)]. MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥ 2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen. Levofloxacin is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae[see Dosage and Administration (2.1) and Clinical Studies (14.3)]. 1.4 Complicated Skin and Skin Structure Infections. Levofloxacin is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)]. 1.5 Uncomplicated Skin and Skin Structure Infections. Levofloxacin is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Chronic Bacterial Prostatitis. Levofloxacin is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)]. 1.7 Inhalational Anthrax (Post-Exposure). Levofloxacin is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)]. 1.8 Plague. Levofloxacin is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of levofloxacin could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Dosage and Administration (2.1,2.2) and Clinical Studies (14.10)]. 1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen. Levofloxacin is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)]. 1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen. Levofloxacin is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)]. 1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen. Levofloxacin is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)]. 1.12 Uncomplicated Urinary Tract Infections. Levofloxacin is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.15)] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. 1.13 Acute Bacterial Exacerbation of Chronic Bronchitis. Levofloxacin is indicated for the treatment of acute bacterial exacerbation (ABS) of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1to 5.15)] and for some patients ABECB is self-limiting, reserve levofloxacin for treatment of ABECB in patients who have no alternative treatment options. 1.14 Acute Bacterial Sinusitis: 5-day and 10 to 14 day Treatment Regimens. Levofloxacin is indicated for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)]. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1to 5.15)] and for some patients ABS is self-limiting, reserve levofloxacin for treatment of ABS in patients who have no alternative treatment options. 1.15 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.",
"Description": "[levofloxacinfigure1]. Levofloxacin, USP is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin, USP The molecular formula is C18H20FN3O4 1/2 H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish-white to yellow-white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin, USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage Form Levofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg: croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. 500 mg: croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. 750 mg: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Levofloxacin tablets, USP meets USP Dissolution Test 2."
},
{
"NDCCode": "63323-426-05",
"PackageDescription": "10 VIAL in 1 TRAY (63323-426-05) / 5 mL in 1 VIAL (63323-426-02) ",
"NDC11Code": "63323-0426-05",
"ProductNDC": "63323-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078651",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-27",
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"StartMarketingDatePackage": "20091213",
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"IndicationAndUsage": "Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3 α-hydroxy-2β-(4-morpholinyl)-5 α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide."
},
{
"NDCCode": "63323-426-10",
"PackageDescription": "10 VIAL in 1 TRAY (63323-426-10) / 10 mL in 1 VIAL (63323-426-01) ",
"NDC11Code": "63323-0426-10",
"ProductNDC": "63323-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078651",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-27",
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"StartMarketingDatePackage": "20091213",
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"IndicationAndUsage": "Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3 α-hydroxy-2β-(4-morpholinyl)-5 α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide."
},
{
"NDCCode": "63323-426-15",
"PackageDescription": "10 VIAL in 1 TRAY (63323-426-15) / 5 mL in 1 VIAL (63323-426-12) ",
"NDC11Code": "63323-0426-15",
"ProductNDC": "63323-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078651",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20091213",
"SamplePackage": "N",
"IndicationAndUsage": "Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3 α-hydroxy-2β-(4-morpholinyl)-5 α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide."
},
{
"NDCCode": "64193-426-02",
"PackageDescription": "1 KIT in 1 CARTON (64193-426-02) * 10 mL in 1 VIAL, GLASS (64193-326-01) * 10 mL in 1 VIAL, GLASS (64764-516-10) ",
"NDC11Code": "64193-0426-02",
"ProductNDC": "64193-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Feiba",
"NonProprietaryName": "Anti-inhibitor Coagulant Complex",
"DosageFormName": "KIT",
"StartMarketingDate": "19860131",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101447",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19860131",
"SamplePackage": "N",
"IndicationAndUsage": "FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: 1 Control and prevention of bleeding episodes, 2 Perioperative management, 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.",
"Description": "FEIBA (Anti-Inhibitor Coagulant Complex) is a freeze-dried sterile human plasma fraction with factor VIII inhibitor bypassing activity to be reconstituted for intravenous administration. Factor VIII inhibitor bypassing activity is expressed in arbitrary units. One unit of activity is defined as that amount of FEIBA that shortens the aPTT of high titer factor VIII inhibitor reference plasma to 50% of the blank value. FEIBA contains mainly non-activated factors II, IX, and X and mainly activated factor VII. It contains approximately equal unitages of factor VIII inhibitor bypassing activity and prothrombin complex factors. In addition, the preparation contains 1-6 units of factor VIII coagulant antigen (FVIII C:Ag) per mL. The product contains traces of factors of the kinin generating system. It contains no heparin. Reconstituted FEIBA contains 4 mg of trisodium citrate and 8 mg of sodium chloride per mL. FEIBA is manufactured from large pools of human plasma. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of FEIBA is collected at FDA approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) Mini-pools of the plasma are tested and found negative for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT). To reduce the risk of viral transmission, the manufacturing process of FEIBA includes two dedicated and independent virus removal/inactivation steps namely 35 nm nanofiltration and a vapor heat treatment process. In addition, the DEAE-Sephadex adsorption contributes to the virus safety profile of FEIBA. In vitro spiking studies have been used to validate the capability of the manufacturing process to remove and inactivate viruses. Table 4 summarizes the results of the viral clearance studies for FEIBA."
},
{
"NDCCode": "65293-426-10",
"PackageDescription": "10 VIAL in 1 TRAY (65293-426-10) > 5 mL in 1 VIAL (65293-426-05)",
"NDC11Code": "65293-0426-10",
"ProductNDC": "65293-426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078651",
"LabelerName": "The Medicines Company",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-12-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "67091-426-20",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (67091-426-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "67091-0426-20",
"ProductNDC": "67091-426",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu Hbp",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240409",
"EndMarketingDate": "20260831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "WinCo Foods, LLC",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "325; 2",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: headachesneezingrunny noseminor aches and painssore throat. temporarily reduces fever."
}
]
}
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<NDC>
<NDCCode>51224-426-10</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE (51224-426-10) </PackageDescription>
<NDC11Code>51224-0426-10</NDC11Code>
<ProductNDC>51224-426</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetrabenazine</ProprietaryName>
<NonProprietaryName>Tetrabenazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207682</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>TETRABENAZINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tetrabenazine tablet is indicated for the treatment of chorea associated with Huntington's disease.</IndicationAndUsage>
<Description>TETRABENAZINE is a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.43; the pKa is 6 .51. Tetrabenazine is a hexahydro-dimethoxy-benzoquinolizine derivative and has the following chemical name: cis rac –1, 3, 4, 6, 7, 11b-hexahydro-9, 10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one.The empirical formula C19H27NO3 is represented by the following structural formula. Tetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol. Each Tetrabenazine tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient. Tetrabenazine tablet contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose, magnesium stearate, maize starch, and talc. The 25 mg strength tablet also contains yellow iron oxide as an inactive ingredient. Tetrabenazine tablet is supplied as a yellowish-buff scored tablet containing 25 mg of TETRABENAZINE or as a white non-scored tablet containing 12.5 mg of TETRABENAZINE.</Description>
</NDC>
<NDC>
<NDCCode>51224-009-10</NDCCode>
<PackageDescription>201.6 g in 1 CAN (51224-009-10) </PackageDescription>
<NDC11Code>51224-0009-10</NDC11Code>
<ProductNDC>51224-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cholestyramine Light</ProprietaryName>
<NonProprietaryName>Cholestyramine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201112</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209599</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>CHOLESTYRAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/4.8g</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201112</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1) Cholestyramine for oral suspension USP, light 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 for oral suspension USP, light 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 resin, 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 resin 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 resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP4 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 resin monotherapy has been demonstrated to retard the rate of progression2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) Cholestyramine for oral suspension USP, light is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin 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, light, 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. Cholestyramine resin is not absorbed from the digestive tract. Each 4.8 grams of cholestyramine for oral suspension USP, light contain 4 grams of cholestyramine resin. It is represented by the following structural formula. Inactive Ingredients: aspartame, citric acid anhydrous, colloidal silicon dioxide, propylene glycol alginate, xanthan gum, natural orange flavor, D&C yellow No. 10 aluminum lake and FD&C yellow No. 6 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>51224-011-10</NDCCode>
<PackageDescription>348.6 g in 1 CAN (51224-011-10) </PackageDescription>
<NDC11Code>51224-0011-10</NDC11Code>
<ProductNDC>51224-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cholestyramine</ProprietaryName>
<NonProprietaryName>Cholestyramine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210310</StartMarketingDate>
<EndMarketingDate>20261130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209597</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>CHOLESTYRAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/8.3g</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210310</StartMarketingDatePackage>
<EndMarketingDatePackage>20261130</EndMarketingDatePackage>
<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 for Oral Suspension, USP 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 resin, 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 resin, 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 resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP4 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 resin monotherapy has been demonstrated to retard the rate of progression2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) Cholestyramine for Oral Suspension, USP is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin 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. Cholestyramine resin is not absorbed from the digestive tract. 8.3 grams of Cholestyramine for Oral Suspension, USP contain 4 grams of cholestyramine resin. It is represented by the following structural formula. Inactive ingredients: sucrose (429.5 mg/g), propylene glycol alginate, natural orange flavor, anhydrous citric acid, D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>51224-012-10</NDCCode>
<PackageDescription>10 CARTON in 1 TRAY (51224-012-10) / 1 VIAL in 1 CARTON (51224-012-20) / 1 INJECTION in 1 VIAL</PackageDescription>
<NDC11Code>51224-0012-10</NDC11Code>
<ProductNDC>51224-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentolamine Mesylate</ProprietaryName>
<NonProprietaryName>Phentolamine Mesylate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20170715</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207686</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>PHENTOLAMINE MESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170715</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentolamine Mesylate for Injection, USP is indicated for the prevention or control of hypertensive episodes that may occur in a patient with pheochromocytoma as a result of stress or manipulation during preoperative preparation and surgical excision. Phentolamine Mesylate for Injection, USP is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine. Phentolamine Mesylate for Injection, USP is also indicated for the diagnosis of pheochromocytoma by the Phentolamine Mesylate for Injection, USP blocking test.</IndicationAndUsage>
<Description>Phentolamine Mesylate for Injection, USP is an antihypertensive, available in vials for intravenous and intramuscular administration. Each vial contains phentolamine mesylate, USP, 5 mg, and mannitol USP, 25 mg, in sterile, lyophilized form. Phentolamine Mesylate, USP is 4,5-dihydro-2-[N-(m-hydroxyphenyl)-N-(p-methylphenyl) aminomethyl]-1H-imidazole 1:1 methanesulfonate, and its structural formula is. Phentolamine mesylate, USP is a white or off-white, odorless crystalline powder with a molecular weight of 377.46. Its solutions are acid to litmus. It is freely soluble in water and in alcohol, and slightly soluble in chloroform. It melts at about 178°C.</Description>
</NDC>
<NDC>
<NDCCode>51224-013-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (51224-013-10) / 5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>51224-0013-10</NDC11Code>
<ProductNDC>51224-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209781</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181130</StartMarketingDatePackage>
<EndMarketingDatePackage>20260810</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) . Levetiracetam injection is indicated for adjunctive therapy for the treatment of:. Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) . Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) . Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible ( 1.4) .</IndicationAndUsage>
<Description>Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection contains 100 mg of levetiracetam per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [ see Dosage and Administration ( 2.6) ].</Description>
</NDC>
<NDC>
<NDCCode>51224-015-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (51224-015-10) > 20 mL in 1 VIAL (51224-015-01) </PackageDescription>
<NDC11Code>51224-0015-10</NDC11Code>
<ProductNDC>51224-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212857</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51224-215-10</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (51224-215-10) > 100 mL in 1 BOTTLE (51224-215-01) </PackageDescription>
<NDC11Code>51224-0215-10</NDC11Code>
<ProductNDC>51224-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212857</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51224-300-10</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (51224-300-10)</PackageDescription>
<NDC11Code>51224-0300-10</NDC11Code>
<ProductNDC>51224-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Codeine Sulfate</ProprietaryName>
<NonProprietaryName>Codeine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202245</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>CODEINE SULFATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-01-16</LastUpdate>
</NDC>
<NDC>
<NDCCode>51224-301-10</NDCCode>
<PackageDescription>4 BOTTLE, UNIT-DOSE in 1 CARTON (51224-301-10) > 75 mL in 1 BOTTLE, UNIT-DOSE</PackageDescription>
<NDC11Code>51224-0301-10</NDC11Code>
<ProductNDC>51224-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130225</StartMarketingDate>
<EndMarketingDate>20220430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090520</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/75mL</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130225</StartMarketingDatePackage>
<EndMarketingDatePackage>20220430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51224-400-10</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (51224-400-10) > 100 g in 1 CAN</PackageDescription>
<NDC11Code>51224-0400-10</NDC11Code>
<ProductNDC>51224-400</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide Emollient</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131011</StartMarketingDate>
<EndMarketingDate>20200831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>TAGI Pharma Inc.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>53</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131011</StartMarketingDatePackage>
<EndMarketingDatePackage>20200831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51224-401-10</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (51224-401-10) > 100 g in 1 CAN</PackageDescription>
<NDC11Code>51224-0401-10</NDC11Code>
<ProductNDC>51224-401</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide Emollient</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131011</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>TAGI Pharma Inc.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>98</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-02-29</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51224-425-10</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE (51224-425-10) </PackageDescription>
<NDC11Code>51224-0425-10</NDC11Code>
<ProductNDC>51224-425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetrabenazine</ProprietaryName>
<NonProprietaryName>Tetrabenazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207682</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>TETRABENAZINE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tetrabenazine tablet is indicated for the treatment of chorea associated with Huntington's disease.</IndicationAndUsage>
<Description>TETRABENAZINE is a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.43; the pKa is 6 .51. Tetrabenazine is a hexahydro-dimethoxy-benzoquinolizine derivative and has the following chemical name: cis rac –1, 3, 4, 6, 7, 11b-hexahydro-9, 10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one.The empirical formula C19H27NO3 is represented by the following structural formula. Tetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol. Each Tetrabenazine tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient. Tetrabenazine tablet contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose, magnesium stearate, maize starch, and talc. The 25 mg strength tablet also contains yellow iron oxide as an inactive ingredient. Tetrabenazine tablet is supplied as a yellowish-buff scored tablet containing 25 mg of TETRABENAZINE or as a white non-scored tablet containing 12.5 mg of TETRABENAZINE.</Description>
</NDC>
<NDC>
<NDCCode>31722-426-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (31722-426-10) </PackageDescription>
<NDC11Code>31722-0426-10</NDC11Code>
<ProductNDC>31722-426</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214344</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.597 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>33342-426-10</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (33342-426-10) </PackageDescription>
<NDC11Code>33342-0426-10</NDC11Code>
<ProductNDC>33342-426</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorthalidone</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212229</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.</IndicationAndUsage>
<Description>Chlorthalidone is an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1-hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, stearic acid. The 50 mg tablets also contain FD&C Blue No.1 Aluminum Lake. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42494-426-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (42494-426-10) </PackageDescription>
<NDC11Code>42494-0426-10</NDC11Code>
<ProductNDC>42494-426</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorzoxazone</ProprietaryName>
<NonProprietaryName>Chlorzoxazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212254</ApplicationNumber>
<LabelerName>Cameron Pharmaceuticals</LabelerName>
<SubstanceName>CHLORZOXAZONE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Chlorzoxazone USP is a centrally acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. Its chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is. C7H4CINO2MW 169.57. Chlorzoxazone USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. Chlorzoxazone tablets contain the inactive ingredients Pregelatinized Starch, Croscarmellose Sodium, Microcrystalline Cellulose, Docusate Sodium, Sodium Benzoate, Colloidal Silicon dioxide, Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>43063-426-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (43063-426-10) </PackageDescription>
<NDC11Code>43063-0426-10</NDC11Code>
<ProductNDC>43063-426</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040256</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43602-426-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (43602-426-10) </PackageDescription>
<NDC11Code>43602-0426-10</NDC11Code>
<ProductNDC>43602-426</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215259</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>.175</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine sodium tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxyanisole, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate and color additive(s). Table 6 provides a listing of the color additives by tablet strength. FDA approved Dissolution test differs from the USP dissolution test. FDA approved Assay test differs from the USP assay test.</Description>
</NDC>
<NDC>
<NDCCode>49281-426-50</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-426-50) / .5 mg in 1 SYRINGE, GLASS (49281-426-88) </PackageDescription>
<NDC11Code>49281-0426-50</NDC11Code>
<ProductNDC>49281-426</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluzone Trivalent Northern Hemisphere</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/michigan/105/2025 San-049a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/tokyo/eis13-175/2025 Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240702</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103914</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mg; ug/.5mg; ug/.5mg</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240702</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluzone® is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.</IndicationAndUsage>
<Description>Fluzone (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone. No presentation of Fluzone is made with natural rubber latex. Fluzone is formulated to contain HA of each of the following three influenza strains recommended for the 2026-2027 influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Michigan/105/2025 SAN-049A (A/Darwin/1454/2025-like virus) (H3N2), and B/Tokyo/EIS13-175/2025 (B Victoria lineage). These three influenza virus strains are recommended by FDA for the 2026-2027 influenza season. The amounts of HA and other ingredients per dose of vaccine are listed in Table 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multiple-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multiple-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multiple-dose vial contains 12.5 mcg mercury.</Description>
</NDC>
<NDC>
<NDCCode>51013-426-48</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (51013-426-48) > 10 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>51013-0426-48</NDC11Code>
<ProductNDC>51013-426</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52685-426-21</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (52685-426-21) > 10 g in 1 CONTAINER</PackageDescription>
<NDC11Code>52685-0426-21</NDC11Code>
<ProductNDC>52685-426</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido The Makeup Foundation</ProprietaryName>
<ProprietaryNameSuffix>B20</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20010101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>410</StrengthNumber>
<StrengthUnit>mg/10g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54575-426-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-426-10)</PackageDescription>
<NDC11Code>54575-0426-10</NDC11Code>
<ProductNDC>54575-426</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Papaya</ProprietaryName>
<NonProprietaryName>Papaya</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>PAPAYA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
</NDC>
<NDC>
<NDCCode>55150-426-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (55150-426-10) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-426-01) </PackageDescription>
<NDC11Code>55150-0426-10</NDC11Code>
<ProductNDC>55150-426</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216552</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride injection is indicated for the following:Atrial Fibrillation or Atrial FlutterTemporary 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.Paroxysmal Supraventricular TachycardiaRapid 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.The use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium.For either indication and particularly when employing continuous intravenous infusion, the setting should include continuous monitoring of the ECG and frequent measurement of blood pressure. A defibrillator and emergency equipment should be readily available.In domestic controlled trials in patients with atrial fibrillation or atrial flutter, bolus administration of diltiazem hydrochloride injection was effective in reducing heart rate by at least 20% in 95% of patients. Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. Following administration of one or two intravenous bolus doses of diltiazem hydrochloride injection, response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes. Heart rate reduction may last from 1 to 3 hours. If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours.A 24 hour continuous infusion of diltiazem hydrochloride injection in the treatment of atrial fibrillation or atrial flutter maintained at least a 20% heart rate reduction during the infusion in 83% of patients. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). Hypotension, if it occurs, may be similarly persistent.In the controlled clinical trials, 3.2% of patients required some form of intervention (typically, use of intravenous fluids or the Trendelenburg position) for blood pressure support following diltiazem hydrochloride injection.In domestic controlled trials, bolus administration of diltiazem hydrochloride injection was effective in converting PSVT to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose.Symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular 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 chemical structure is. Diltiazem hydrochloride, USP is a white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 451.0. 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. 25-mg, 5-mL vial–each sterile vial contains 25 mg diltiazem hydrochloride, 3.75 mg citric acid USP, 3.25 mg sodium citrate dihydrate USP, 357 mg sorbitol solution USP, and water for injection USP up to 5 mL. Sodium hydroxide or hydrochloric acid is used for pH adjustment. 50-mg, 10-mL vial–each sterile vial contains 50 mg diltiazem hydrochloride, 7.5 mg citric acid USP, 6.5 mg sodium citrate dihydrate USP, 714 mg sorbitol solution USP, and water for injection USP up to 10 mL. Sodium hydroxide or hydrochloric acid is used for pH adjustment. 125-mg, 25-mL vial–each sterile vial contains 125 mg diltiazem hydrochloride, 18.75 mg citric acid USP, 16.25 mg sodium citrate dihydrate USP, 1,785 mg sorbitol solution USP, and water for injection USP up to 25 mL. Sodium hydroxide or hydrochloric acid is used for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>61703-434-82</NDCCode>
<PackageDescription>10 KIT in 1 PACKAGE (61703-434-82) > 1 KIT in 1 KIT (61703-434-01) * 5 mL in 1 VIAL, SINGLE-DOSE (61703-426-02) * 5 mL in 1 VIAL, SINGLE-DOSE (61703-430-02) </PackageDescription>
<NDC11Code>61703-0434-82</NDC11Code>
<ProductNDC>61703-434</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>M.v.i. Adult</ProprietaryName>
<NonProprietaryName>Retinol, Ergocalciferol, .alpha.-tocopherol Acetate, Dl-, Phytonadione, Ascorbic Acid, Niacinamide, Riboflavin 5-phosphate Sodium, Thiamine Hydrochloride, Pyridoxine Hydrochloride, Dexpanthenol, Biotin, Folic Acid, And Cyanocobalamin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021625</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61919-426-10</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (61919-426-10) </PackageDescription>
<NDC11Code>61919-0426-10</NDC11Code>
<ProductNDC>61919-426</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202801</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. 1.1 Nosocomial Pneumonia. Levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen. Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae[see Dosage and Administration (2.1) and Clinical Studies (14.2)]. MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥ 2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen. Levofloxacin is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae[see Dosage and Administration (2.1) and Clinical Studies (14.3)]. 1.4 Complicated Skin and Skin Structure Infections. Levofloxacin is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)]. 1.5 Uncomplicated Skin and Skin Structure Infections. Levofloxacin is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Chronic Bacterial Prostatitis. Levofloxacin is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)]. 1.7 Inhalational Anthrax (Post-Exposure). Levofloxacin is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)]. 1.8 Plague. Levofloxacin is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of levofloxacin could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Dosage and Administration (2.1,2.2) and Clinical Studies (14.10)]. 1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen. Levofloxacin is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)]. 1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen. Levofloxacin is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)]. 1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen. Levofloxacin is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)]. 1.12 Uncomplicated Urinary Tract Infections. Levofloxacin is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.15)] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. 1.13 Acute Bacterial Exacerbation of Chronic Bronchitis. Levofloxacin is indicated for the treatment of acute bacterial exacerbation (ABS) of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1to 5.15)] and for some patients ABECB is self-limiting, reserve levofloxacin for treatment of ABECB in patients who have no alternative treatment options. 1.14 Acute Bacterial Sinusitis: 5-day and 10 to 14 day Treatment Regimens. Levofloxacin is indicated for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)]. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1to 5.15)] and for some patients ABS is self-limiting, reserve levofloxacin for treatment of ABS in patients who have no alternative treatment options. 1.15 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.</IndicationAndUsage>
<Description>[levofloxacinfigure1]. Levofloxacin, USP is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin, USP The molecular formula is C18H20FN3O4 1/2 H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish-white to yellow-white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin, USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage Form Levofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg: croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. 500 mg: croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. 750 mg: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Levofloxacin tablets, USP meets USP Dissolution Test 2.</Description>
</NDC>
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<PackageDescription>10 VIAL in 1 TRAY (63323-426-05) / 5 mL in 1 VIAL (63323-426-02) </PackageDescription>
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<IndicationAndUsage>Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3 α-hydroxy-2β-(4-morpholinyl)-5 α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide.</Description>
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<PackageDescription>10 VIAL in 1 TRAY (63323-426-10) / 10 mL in 1 VIAL (63323-426-01) </PackageDescription>
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<IndicationAndUsage>Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3 α-hydroxy-2β-(4-morpholinyl)-5 α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide.</Description>
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<NDCCode>63323-426-15</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (63323-426-15) / 5 mL in 1 VIAL (63323-426-12) </PackageDescription>
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<ProprietaryName>Rocuronium</ProprietaryName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3 α-hydroxy-2β-(4-morpholinyl)-5 α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>64193-426-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (64193-426-02) * 10 mL in 1 VIAL, GLASS (64193-326-01) * 10 mL in 1 VIAL, GLASS (64764-516-10) </PackageDescription>
<NDC11Code>64193-0426-02</NDC11Code>
<ProductNDC>64193-426</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Feiba</ProprietaryName>
<NonProprietaryName>Anti-inhibitor Coagulant Complex</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19860131</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101447</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: 1 Control and prevention of bleeding episodes, 2 Perioperative management, 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>FEIBA (Anti-Inhibitor Coagulant Complex) is a freeze-dried sterile human plasma fraction with factor VIII inhibitor bypassing activity to be reconstituted for intravenous administration. Factor VIII inhibitor bypassing activity is expressed in arbitrary units. One unit of activity is defined as that amount of FEIBA that shortens the aPTT of high titer factor VIII inhibitor reference plasma to 50% of the blank value. FEIBA contains mainly non-activated factors II, IX, and X and mainly activated factor VII. It contains approximately equal unitages of factor VIII inhibitor bypassing activity and prothrombin complex factors. In addition, the preparation contains 1-6 units of factor VIII coagulant antigen (FVIII C:Ag) per mL. The product contains traces of factors of the kinin generating system. It contains no heparin. Reconstituted FEIBA contains 4 mg of trisodium citrate and 8 mg of sodium chloride per mL. FEIBA is manufactured from large pools of human plasma. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of FEIBA is collected at FDA approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) Mini-pools of the plasma are tested and found negative for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT). To reduce the risk of viral transmission, the manufacturing process of FEIBA includes two dedicated and independent virus removal/inactivation steps namely 35 nm nanofiltration and a vapor heat treatment process. In addition, the DEAE-Sephadex adsorption contributes to the virus safety profile of FEIBA. In vitro spiking studies have been used to validate the capability of the manufacturing process to remove and inactivate viruses. Table 4 summarizes the results of the viral clearance studies for FEIBA.</Description>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<LabelerName>The Medicines Company</LabelerName>
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<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<PackageDescription>2 BLISTER PACK in 1 CARTON (67091-426-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>67091-0426-20</NDC11Code>
<ProductNDC>67091-426</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu Hbp</ProprietaryName>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240409</StartMarketingDate>
<EndMarketingDate>20260831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>WinCo Foods, LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>325; 2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240409</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: headachesneezingrunny noseminor aches and painssore throat. temporarily reduces fever.</IndicationAndUsage>
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