{
"NDC": [
{
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"PackageDescription": "45 TABLET in 1 BOTTLE (71335-0174-8) ",
"NDC11Code": "71335-0174-08",
"ProductNDC": "71335-0174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077290",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "38779-0174-8",
"PackageDescription": "500 g in 1 JAR (38779-0174-8) ",
"NDC11Code": "38779-0174-08",
"ProductNDC": "38779-0174",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Danazol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140711",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "DANAZOL",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-14",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "11-JUL-14"
},
{
"NDCCode": "58118-0174-8",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (58118-0174-8)",
"NDC11Code": "58118-0174-08",
"ProductNDC": "58118-0174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078895",
"LabelerName": "Clinical Solutions Wholesale, LLC",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-11",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "71335-0174-1",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-0174-1) ",
"NDC11Code": "71335-0174-01",
"ProductNDC": "71335-0174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077290",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0174-2",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-0174-2) ",
"NDC11Code": "71335-0174-02",
"ProductNDC": "71335-0174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077290",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0174-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (71335-0174-3) ",
"NDC11Code": "71335-0174-03",
"ProductNDC": "71335-0174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077290",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0174-4",
"PackageDescription": "120 TABLET in 1 BOTTLE (71335-0174-4) ",
"NDC11Code": "71335-0174-04",
"ProductNDC": "71335-0174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077290",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0174-5",
"PackageDescription": "100 TABLET in 1 BOTTLE (71335-0174-5) ",
"NDC11Code": "71335-0174-05",
"ProductNDC": "71335-0174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077290",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0174-6",
"PackageDescription": "56 TABLET in 1 BOTTLE (71335-0174-6) ",
"NDC11Code": "71335-0174-06",
"ProductNDC": "71335-0174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077290",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0174-7",
"PackageDescription": "84 TABLET in 1 BOTTLE (71335-0174-7) ",
"NDC11Code": "71335-0174-07",
"ProductNDC": "71335-0174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077290",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0174-9",
"PackageDescription": "18 TABLET in 1 BOTTLE (71335-0174-9) ",
"NDC11Code": "71335-0174-09",
"ProductNDC": "71335-0174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077290",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "13630-0174-4",
"PackageDescription": "155 g in 1 CAN (13630-0174-4) ",
"NDC11Code": "13630-0174-04",
"ProductNDC": "13630-0174",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Panama Jack",
"ProprietaryNameSuffix": "Spf 8",
"NonProprietaryName": "Avobenzone, Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190507",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Prime Packaging, Inc.",
"SubstanceName": "AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "2; 2",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190507",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "17312-174-13",
"PackageDescription": "1 TUBE in 1 PACKAGE (17312-174-13) > 4 g in 1 TUBE",
"NDC11Code": "17312-0174-13",
"ProductNDC": "17312-174",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eye Strain Relief Pm",
"NonProprietaryName": "Conium Maculatum, Euphrasia, Natrium Muriaticum, Physostigma Venenosum, Ruta Graveolens, Senega Officinalis, Valeriana Officinalis",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190415",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; PHYSOSTIGMA VENENOSUM SEED; POLYGALA SENEGA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE; VALERIAN",
"StrengthNumber": "6; 6; 13; 6; 6; 8; 6",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190415",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. According to homeopathic indications these ingredients provide temporary relief from symptoms such as: Dry, red, tired eyes Eye strain Headache Double vision Difficulty focusing Difficulty reading Eye fatigue irritated eyes Sleeplessness; after serious causes have been ruled out by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "17478-174-24",
"PackageDescription": "2 POUCH in 1 CARTON (17478-174-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH (17478-174-12) > 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "17478-0174-24",
"ProductNDC": "17478-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xopenex",
"NonProprietaryName": "Levalbuterol Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020837",
"LabelerName": "Akorn",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150227",
"SamplePackage": "N",
"IndicationAndUsage": "XOPENEX (levalbuterol HCl) Inhalation Solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
"Description": "XOPENEX Inhalation Solution is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl) amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. XOPENEX Inhalation Solution is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg of levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
},
{
"NDCCode": "21695-174-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (21695-174-60)",
"NDC11Code": "21695-0174-60",
"ProductNDC": "21695-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nefazodone Hydrochloride",
"NonProprietaryName": "Nefazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076037",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "NEFAZODONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS). In many cases, this would lead to the conclusion that other drugs should be tried first. The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of nefazodone in reducing relapse in patients with major depression who were judged to have had a satisfactory clinical response to 16 weeks of open-label nefazodone treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see CLINICAL PHARMACOLOGY). Although remitted patients were followed for as long as 36 weeks in the study cited (i.e., 52 weeks total), the physician who elects to use nefazodone for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Nefazodone hydrochloride tablets are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI). Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one monohydrochloride. The structural formula is. C25H32CIN5O2HCl M.W. 506.5. Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water. Nefazodone hydrochloride tablets are supplied as capsule-shaped tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and povidone. Additionally, the 50 mg tablets include ferric oxide red as a colorant, the 150 mg tablets include ferric oxide red and yellow as colorants, and the 200 mg tablets include ferric oxide yellow as a colorant."
},
{
"NDCCode": "27241-174-56",
"PackageDescription": "56 TABLET, FILM COATED in 1 BOTTLE (27241-174-56) ",
"NDC11Code": "27241-0174-56",
"ProductNDC": "27241-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213019",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is off-white to light fawn powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and slightly soluble in N, N-dimethyl Formamide. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg off-white, capsule shaped, biconvex, film-coated tablets, debossed with ‘V1’ on one side and plain on other side and a 1 mg blue colored, capsule shaped, biconvex, film-coated tablets, debossed with ‘V2’ on one side and plain on other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, maltodextrin. The film coating contains hypromellose, titanium dioxide, polyethylene glycol. 1 mg has FD&C Blue # 2 and FD&C yellow # 6."
},
{
"NDCCode": "27241-174-77",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (27241-174-77) / 56 TABLET, FILM COATED in 1 BLISTER PACK (27241-174-11) ",
"NDC11Code": "27241-0174-77",
"ProductNDC": "27241-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213019",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is off-white to light fawn powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and slightly soluble in N, N-dimethyl Formamide. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg off-white, capsule shaped, biconvex, film-coated tablets, debossed with ‘V1’ on one side and plain on other side and a 1 mg blue colored, capsule shaped, biconvex, film-coated tablets, debossed with ‘V2’ on one side and plain on other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, maltodextrin. The film coating contains hypromellose, titanium dioxide, polyethylene glycol. 1 mg has FD&C Blue # 2 and FD&C yellow # 6."
},
{
"NDCCode": "33261-174-08",
"PackageDescription": "8 TABLET in 1 BOTTLE, PLASTIC (33261-174-08)",
"NDC11Code": "33261-0174-08",
"ProductNDC": "33261-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078010",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Furosemide tablets, USP is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is available as white to off white round tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide, USP is a white to slightly yellow odorless crystalline powder. It is practically insoluble in water, soluble in 15 parts of acetone, freely soluble in dimethylformamide and in solution of alkali hydroxides; soluble in methanol; sparingly soluble in alcohol; very slightly soluble in chloroform. The CAS Registry Number is 54-31-9. It has a molecular formula of C12H11ClN2O5S and a molecular weight of 330.75. Tested by USP Dissolution Test 1. The molecular structure is as follows."
},
{
"NDCCode": "42254-174-45",
"PackageDescription": "1 TUBE in 1 CARTON (42254-174-45) > 45 g in 1 TUBE",
"NDC11Code": "42254-0174-45",
"ProductNDC": "42254-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074221",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamicpituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol Propionate Cream and Ointment USP, 0.05% contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9- fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4- diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "50228-174-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-01) ",
"NDC11Code": "50228-0174-01",
"ProductNDC": "50228-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205794",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180420",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .",
"Description": "Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol, and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test2."
},
{
"NDCCode": "50228-174-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-05) ",
"NDC11Code": "50228-0174-05",
"ProductNDC": "50228-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205794",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180420",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .",
"Description": "Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol, and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test2."
},
{
"NDCCode": "50228-174-10",
"PackageDescription": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-10) ",
"NDC11Code": "50228-0174-10",
"ProductNDC": "50228-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205794",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180420",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .",
"Description": "Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol, and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test2."
},
{
"NDCCode": "50228-174-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-30) ",
"NDC11Code": "50228-0174-30",
"ProductNDC": "50228-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205794",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180420",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .",
"Description": "Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol, and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test2."
},
{
"NDCCode": "50228-174-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-60) ",
"NDC11Code": "50228-0174-60",
"ProductNDC": "50228-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205794",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180420",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .",
"Description": "Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol, and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test2."
},
{
"NDCCode": "51523-174-03",
"PackageDescription": "1 TUBE in 1 CARTON (51523-174-03) > 120 mL in 1 TUBE",
"NDC11Code": "51523-0174-03",
"ProductNDC": "51523-174",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natural Sun Eco",
"ProprietaryNameSuffix": "Mild Milk Spf40",
"NonProprietaryName": "Avobenzone, Ensulizole, Octinoxate And Octisalate Lotion",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "THEFACESHOP CO., LTD.",
"SubstanceName": "AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTINOXATE",
"StrengthNumber": "2.76; 4.2; 4.8; 7.8",
"StrengthUnit": "g/120mL; g/120mL; g/120mL; g/120mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "52796-174-01",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (52796-174-01) / 1 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "52796-0174-01",
"ProductNDC": "52796-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Floriva",
"NonProprietaryName": "Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Levomefolate Glucosamine, Folic Acid, Cyanocobalamin, Biotin, Zinc Gluconate, Cupric Oxide, And Sodium Fluoride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20141015",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BonGeo Pharmaceuticals, Inc.",
"SubstanceName": "VITAMIN A ACETATE; BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; ZINC GLUCONATE; CUPRIC OXIDE; SODIUM FLUORIDE",
"StrengthNumber": "1000; 1000; 75; 600; 20; 1.3; 1.5; 15; 1.8; 162; 100; 6; 40; 5; 1; .5",
"StrengthUnit": "[iU]/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141015",
"SamplePackage": "N",
"Description": "Off-white to pale yellow, speckled, berry flavored, hexagon shaped chewable tablet. Debossed \"174\" on one side and scored on the other."
},
{
"NDCCode": "52796-174-90",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (52796-174-90) ",
"NDC11Code": "52796-0174-90",
"ProductNDC": "52796-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Floriva",
"NonProprietaryName": "Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Levomefolate Glucosamine, Folic Acid, Cyanocobalamin, Biotin, Zinc Gluconate, Cupric Oxide, And Sodium Fluoride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20141015",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BonGeo Pharmaceuticals, Inc.",
"SubstanceName": "VITAMIN A ACETATE; BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; ZINC GLUCONATE; CUPRIC OXIDE; SODIUM FLUORIDE",
"StrengthNumber": "1000; 1000; 75; 600; 20; 1.3; 1.5; 15; 1.8; 162; 100; 6; 40; 5; 1; .5",
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"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-02",
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"ProductNdcExcludeFlag": "N",
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"Description": "Off-white to pale yellow, speckled, berry flavored, hexagon shaped chewable tablet. Debossed \"174\" on one side and scored on the other."
},
{
"NDCCode": "54288-174-05",
"PackageDescription": "5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (54288-174-05) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (54288-174-01) ",
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"ProductNDC": "54288-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"NonProprietaryName": "Selenious Acid",
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"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241031",
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"LabelerName": "BPI Labs LLC",
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"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20241031",
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"IndicationAndUsage": "Selenium Injection is indicated for use as a supplement to intravenous solutions given for Total Parenteral Nutrition (TPN). Administration of selenium in TPN solutions helps to maintain plasma selenium levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.",
"Description": "Selenium Injection is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains Selenious Acid 65.4 mcg (equivalent to elemental selenium 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4."
},
{
"NDCCode": "55150-174-10",
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"ProductNDC": "55150-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "INTRAVENOUS",
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"MarketingCategoryName": "ANDA",
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"LabelerName": "Eugia US LLC",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
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"IndicationAndUsage": "Azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of the following infections caused by designated susceptible microorganisms: 1 Community-acquired pneumonia in adults (1.1), 2 Pelvic inflammatory disease in adults (1.2).",
"Description": "Azithromycin for injection, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula: Azithromycin, as the monohydrate, is a white to almost white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.02. Azithromycin for injection, USP is a sterile preparation consisting of azithromycin monohydrate USP and the following inactive ingredients: anhydrous citric acid and sodium hydroxide. Sodium hydroxide is added to adjust the pH. Azithromycin for injection, USP is supplied as white lyophilized cake in a single-dose vial for intravenous administration. Each vial contains azithromycin monohydrate equivalent to 500 mg of azithromycin, 413.6 mg anhydrous citric acid, and sodium hydroxide. Reconstitution, according to label directions, results in approximately 5 mL of azithromycin for intravenous injection with each mL containing 102.4 mg of azithromycin monohydrate USP equivalent to 100 mg of azithromycin, 82.72 mg of citric acid, and sodium hydroxide."
},
{
"NDCCode": "57237-174-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (57237-174-01) ",
"NDC11Code": "57237-0174-01",
"ProductNDC": "57237-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090555",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100407",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder.The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride USP is a white or almost white crystalline powder with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43.Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, ferric oxide brown, ferric oxide yellow, povidone (Kollidone 30), and magnesium stearate."
}
]
}
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<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<LastUpdate>2022-01-25</LastUpdate>
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<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<Status>Deprecated</Status>
<LastUpdate>2022-01-25</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<Status>Deprecated</Status>
<LastUpdate>2022-01-25</LastUpdate>
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<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<Status>Deprecated</Status>
<LastUpdate>2022-01-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<Status>Deprecated</Status>
<LastUpdate>2022-01-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>13630-0174-4</NDCCode>
<PackageDescription>155 g in 1 CAN (13630-0174-4) </PackageDescription>
<NDC11Code>13630-0174-04</NDC11Code>
<ProductNDC>13630-0174</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Panama Jack</ProprietaryName>
<ProprietaryNameSuffix>Spf 8</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190507</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Packaging, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>2; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17312-174-13</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (17312-174-13) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17312-0174-13</NDC11Code>
<ProductNDC>17312-174</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eye Strain Relief Pm</ProprietaryName>
<NonProprietaryName>Conium Maculatum, Euphrasia, Natrium Muriaticum, Physostigma Venenosum, Ruta Graveolens, Senega Officinalis, Valeriana Officinalis</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190415</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; PHYSOSTIGMA VENENOSUM SEED; POLYGALA SENEGA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE; VALERIAN</SubstanceName>
<StrengthNumber>6; 6; 13; 6; 6; 8; 6</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses*. According to homeopathic indications these ingredients provide temporary relief from symptoms such as: Dry, red, tired eyes Eye strain Headache Double vision Difficulty focusing Difficulty reading Eye fatigue irritated eyes Sleeplessness; after serious causes have been ruled out by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17478-174-24</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (17478-174-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH (17478-174-12) > 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>17478-0174-24</NDC11Code>
<ProductNDC>17478-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xopenex</ProprietaryName>
<NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020837</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XOPENEX (levalbuterol HCl) Inhalation Solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>XOPENEX Inhalation Solution is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl) amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. XOPENEX Inhalation Solution is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg of levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).</Description>
</NDC>
<NDC>
<NDCCode>21695-174-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (21695-174-60)</PackageDescription>
<NDC11Code>21695-0174-60</NDC11Code>
<ProductNDC>21695-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nefazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Nefazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076037</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>NEFAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS). In many cases, this would lead to the conclusion that other drugs should be tried first. The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of nefazodone in reducing relapse in patients with major depression who were judged to have had a satisfactory clinical response to 16 weeks of open-label nefazodone treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see CLINICAL PHARMACOLOGY). Although remitted patients were followed for as long as 36 weeks in the study cited (i.e., 52 weeks total), the physician who elects to use nefazodone for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Nefazodone hydrochloride tablets are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI). Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one monohydrochloride. The structural formula is. C25H32CIN5O2HCl M.W. 506.5. Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water. Nefazodone hydrochloride tablets are supplied as capsule-shaped tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and povidone. Additionally, the 50 mg tablets include ferric oxide red as a colorant, the 150 mg tablets include ferric oxide red and yellow as colorants, and the 200 mg tablets include ferric oxide yellow as a colorant.</Description>
</NDC>
<NDC>
<NDCCode>27241-174-56</NDCCode>
<PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (27241-174-56) </PackageDescription>
<NDC11Code>27241-0174-56</NDC11Code>
<ProductNDC>27241-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213019</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is off-white to light fawn powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and slightly soluble in N, N-dimethyl Formamide. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg off-white, capsule shaped, biconvex, film-coated tablets, debossed with ‘V1’ on one side and plain on other side and a 1 mg blue colored, capsule shaped, biconvex, film-coated tablets, debossed with ‘V2’ on one side and plain on other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, maltodextrin. The film coating contains hypromellose, titanium dioxide, polyethylene glycol. 1 mg has FD&C Blue # 2 and FD&C yellow # 6.</Description>
</NDC>
<NDC>
<NDCCode>27241-174-77</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (27241-174-77) / 56 TABLET, FILM COATED in 1 BLISTER PACK (27241-174-11) </PackageDescription>
<NDC11Code>27241-0174-77</NDC11Code>
<ProductNDC>27241-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213019</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is off-white to light fawn powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and slightly soluble in N, N-dimethyl Formamide. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg off-white, capsule shaped, biconvex, film-coated tablets, debossed with ‘V1’ on one side and plain on other side and a 1 mg blue colored, capsule shaped, biconvex, film-coated tablets, debossed with ‘V2’ on one side and plain on other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, maltodextrin. The film coating contains hypromellose, titanium dioxide, polyethylene glycol. 1 mg has FD&C Blue # 2 and FD&C yellow # 6.</Description>
</NDC>
<NDC>
<NDCCode>33261-174-08</NDCCode>
<PackageDescription>8 TABLET in 1 BOTTLE, PLASTIC (33261-174-08)</PackageDescription>
<NDC11Code>33261-0174-08</NDC11Code>
<ProductNDC>33261-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078010</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Furosemide tablets, USP is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is available as white to off white round tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide, USP is a white to slightly yellow odorless crystalline powder. It is practically insoluble in water, soluble in 15 parts of acetone, freely soluble in dimethylformamide and in solution of alkali hydroxides; soluble in methanol; sparingly soluble in alcohol; very slightly soluble in chloroform. The CAS Registry Number is 54-31-9. It has a molecular formula of C12H11ClN2O5S and a molecular weight of 330.75. Tested by USP Dissolution Test 1. The molecular structure is as follows.</Description>
</NDC>
<NDC>
<NDCCode>42254-174-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42254-174-45) > 45 g in 1 TUBE</PackageDescription>
<NDC11Code>42254-0174-45</NDC11Code>
<ProductNDC>42254-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074221</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamicpituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol Propionate Cream and Ointment USP, 0.05% contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9- fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4- diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>50228-174-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-01) </PackageDescription>
<NDC11Code>50228-0174-01</NDC11Code>
<ProductNDC>50228-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205794</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol, and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test2.</Description>
</NDC>
<NDC>
<NDCCode>50228-174-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-05) </PackageDescription>
<NDC11Code>50228-0174-05</NDC11Code>
<ProductNDC>50228-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205794</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol, and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test2.</Description>
</NDC>
<NDC>
<NDCCode>50228-174-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-10) </PackageDescription>
<NDC11Code>50228-0174-10</NDC11Code>
<ProductNDC>50228-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205794</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol, and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test2.</Description>
</NDC>
<NDC>
<NDCCode>50228-174-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-30) </PackageDescription>
<NDC11Code>50228-0174-30</NDC11Code>
<ProductNDC>50228-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205794</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol, and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test2.</Description>
</NDC>
<NDC>
<NDCCode>50228-174-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-60) </PackageDescription>
<NDC11Code>50228-0174-60</NDC11Code>
<ProductNDC>50228-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205794</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol, and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test2.</Description>
</NDC>
<NDC>
<NDCCode>51523-174-03</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51523-174-03) > 120 mL in 1 TUBE</PackageDescription>
<NDC11Code>51523-0174-03</NDC11Code>
<ProductNDC>51523-174</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natural Sun Eco</ProprietaryName>
<ProprietaryNameSuffix>Mild Milk Spf40</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Ensulizole, Octinoxate And Octisalate Lotion</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>THEFACESHOP CO., LTD.</LabelerName>
<SubstanceName>AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTINOXATE</SubstanceName>
<StrengthNumber>2.76; 4.2; 4.8; 7.8</StrengthNumber>
<StrengthUnit>g/120mL; g/120mL; g/120mL; g/120mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52796-174-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (52796-174-01) / 1 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>52796-0174-01</NDC11Code>
<ProductNDC>52796-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Floriva</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Levomefolate Glucosamine, Folic Acid, Cyanocobalamin, Biotin, Zinc Gluconate, Cupric Oxide, And Sodium Fluoride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141015</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BonGeo Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VITAMIN A ACETATE; BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; ZINC GLUCONATE; CUPRIC OXIDE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1000; 1000; 75; 600; 20; 1.3; 1.5; 15; 1.8; 162; 100; 6; 40; 5; 1; .5</StrengthNumber>
<StrengthUnit>[iU]/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Off-white to pale yellow, speckled, berry flavored, hexagon shaped chewable tablet. Debossed "174" on one side and scored on the other.</Description>
</NDC>
<NDC>
<NDCCode>52796-174-90</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (52796-174-90) </PackageDescription>
<NDC11Code>52796-0174-90</NDC11Code>
<ProductNDC>52796-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Floriva</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Levomefolate Glucosamine, Folic Acid, Cyanocobalamin, Biotin, Zinc Gluconate, Cupric Oxide, And Sodium Fluoride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141015</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BonGeo Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VITAMIN A ACETATE; BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; ZINC GLUCONATE; CUPRIC OXIDE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1000; 1000; 75; 600; 20; 1.3; 1.5; 15; 1.8; 162; 100; 6; 40; 5; 1; .5</StrengthNumber>
<StrengthUnit>[iU]/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Off-white to pale yellow, speckled, berry flavored, hexagon shaped chewable tablet. Debossed "174" on one side and scored on the other.</Description>
</NDC>
<NDC>
<NDCCode>54288-174-05</NDCCode>
<PackageDescription>5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (54288-174-05) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (54288-174-01) </PackageDescription>
<NDC11Code>54288-0174-05</NDC11Code>
<ProductNDC>54288-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Selenious Acid</ProprietaryName>
<NonProprietaryName>Selenious Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241031</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BPI Labs LLC</LabelerName>
<SubstanceName>SELENIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Selenium Injection is indicated for use as a supplement to intravenous solutions given for Total Parenteral Nutrition (TPN). Administration of selenium in TPN solutions helps to maintain plasma selenium levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.</IndicationAndUsage>
<Description>Selenium Injection is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains Selenious Acid 65.4 mcg (equivalent to elemental selenium 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.</Description>
</NDC>
<NDC>
<NDCCode>55150-174-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (55150-174-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55150-0174-10</NDC11Code>
<ProductNDC>55150-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203294</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of the following infections caused by designated susceptible microorganisms: 1 Community-acquired pneumonia in adults (1.1), 2 Pelvic inflammatory disease in adults (1.2).</IndicationAndUsage>
<Description>Azithromycin for injection, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula: Azithromycin, as the monohydrate, is a white to almost white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.02. Azithromycin for injection, USP is a sterile preparation consisting of azithromycin monohydrate USP and the following inactive ingredients: anhydrous citric acid and sodium hydroxide. Sodium hydroxide is added to adjust the pH. Azithromycin for injection, USP is supplied as white lyophilized cake in a single-dose vial for intravenous administration. Each vial contains azithromycin monohydrate equivalent to 500 mg of azithromycin, 413.6 mg anhydrous citric acid, and sodium hydroxide. Reconstitution, according to label directions, results in approximately 5 mL of azithromycin for intravenous injection with each mL containing 102.4 mg of azithromycin monohydrate USP equivalent to 100 mg of azithromycin, 82.72 mg of citric acid, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>57237-174-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57237-174-01) </PackageDescription>
<NDC11Code>57237-0174-01</NDC11Code>
<ProductNDC>57237-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090555</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder.The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride USP is a white or almost white crystalline powder with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43.Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, ferric oxide brown, ferric oxide yellow, povidone (Kollidone 30), and magnesium stearate.</Description>
</NDC>
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