{
"NDC": [
{
"NDCCode": "0310-0625-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (0310-0625-28) ",
"NDC11Code": "00310-0625-28",
"ProductNDC": "0310-0625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Koselugo",
"NonProprietaryName": "Selumetinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213756",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "SELUMETINIB",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210611",
"SamplePackage": "N",
"IndicationAndUsage": "KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2)].",
"Description": "KOSELUGO contains selumetinib sulfate, a kinase inhibitor. The chemical name is 5-[(4-bromo-2-chlorophenyl)amino]-4-fluoro-6-[(2-hydroxyethoxy)carbamoyl]-1-methyl-1H-benzimidazol-3-ium hydrogen sulfate. The molecular formula for selumetinib sulfate is C17H17BrClFN4O7S and the relative molecular mass is 555.76 g/mol. Selumetinib sulfate has the following structural formula. Selumetinib sulfate is a white to yellow monomorphic crystalline powder that exhibits a pH dependent solubility. Selumetinib sulfate is freely soluble at pH < 1.5, sparingly soluble in the pH range at 1.5 to 3 and slightly soluble at pH > 3. Selumetinib sulfate has two ionizable functions with pKa values of 2.8 and 8.4. KOSELUGO (selumetinib) 10 mg capsules for oral use, contain 10 mg selumetinib (equivalent to 12.1 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains carnauba wax, carrageenan, hypromellose, potassium chloride, purified water, and titanium dioxide. The capsule is imprinted with black ink that contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. KOSELUGO (selumetinib) 25 mg capsules for oral use, contain 25 mg selumetinib (equivalent to 30.25 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains carnauba wax and/or cornstarch, carrageenan, FD&C blue 2, ferric oxide yellow, hypromellose, potassium chloride, purified water, and titanium dioxide. The capsule is imprinted with black ink that contains carnauba wax, FD&C Blue 2 aluminum lake, ferric oxide red, ferric oxide yellow, glyceryl monooleate, and shellac. KOSELUGO (selumetinib) 5 mg oral granules contain 5 mg selumetinib (equivalent to 6.05 mg selumetinib sulfate). The uncoated cores contain selumetinib sulfate, glyceryl dibehenate, and stearoyl polyoxylglycerides. The granule coating contains acetone, hypromellose acetate succinate, and stearic acid. The capsule shell contains ferric oxide yellow, hypromellose, and titanium dioxide. The capsule shell is imprinted with black ink that contains butyl alcohol, dehydrated alcohol, ferric oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution. KOSELUGO (selumetinib) 7.5 mg oral granules contain 7.5 mg selumetinib (equivalent to 9.08 mg selumetinib sulfate). The uncoated cores contain selumetinib sulfate, glyceryl dibehenate, and stearoyl polyoxylglycerides. The granule coating contains acetone, hypromellose acetate succinate, and stearic acid. The capsule shell contains ferric oxide red, hypromellose, and titanium dioxide. The capsule shell is imprinted with black ink that contains butyl alcohol, dehydrated alcohol, ferric oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution."
},
{
"NDCCode": "0310-0625-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0310-0625-60) ",
"NDC11Code": "00310-0625-60",
"ProductNDC": "0310-0625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Koselugo",
"NonProprietaryName": "Selumetinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213756",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "SELUMETINIB",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200416",
"SamplePackage": "N",
"IndicationAndUsage": "KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2)].",
"Description": "KOSELUGO contains selumetinib sulfate, a kinase inhibitor. The chemical name is 5-[(4-bromo-2-chlorophenyl)amino]-4-fluoro-6-[(2-hydroxyethoxy)carbamoyl]-1-methyl-1H-benzimidazol-3-ium hydrogen sulfate. The molecular formula for selumetinib sulfate is C17H17BrClFN4O7S and the relative molecular mass is 555.76 g/mol. Selumetinib sulfate has the following structural formula. Selumetinib sulfate is a white to yellow monomorphic crystalline powder that exhibits a pH dependent solubility. Selumetinib sulfate is freely soluble at pH < 1.5, sparingly soluble in the pH range at 1.5 to 3 and slightly soluble at pH > 3. Selumetinib sulfate has two ionizable functions with pKa values of 2.8 and 8.4. KOSELUGO (selumetinib) 10 mg capsules for oral use, contain 10 mg selumetinib (equivalent to 12.1 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains carnauba wax, carrageenan, hypromellose, potassium chloride, purified water, and titanium dioxide. The capsule is imprinted with black ink that contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. KOSELUGO (selumetinib) 25 mg capsules for oral use, contain 25 mg selumetinib (equivalent to 30.25 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains carnauba wax and/or cornstarch, carrageenan, FD&C blue 2, ferric oxide yellow, hypromellose, potassium chloride, purified water, and titanium dioxide. The capsule is imprinted with black ink that contains carnauba wax, FD&C Blue 2 aluminum lake, ferric oxide red, ferric oxide yellow, glyceryl monooleate, and shellac. KOSELUGO (selumetinib) 5 mg oral granules contain 5 mg selumetinib (equivalent to 6.05 mg selumetinib sulfate). The uncoated cores contain selumetinib sulfate, glyceryl dibehenate, and stearoyl polyoxylglycerides. The granule coating contains acetone, hypromellose acetate succinate, and stearic acid. The capsule shell contains ferric oxide yellow, hypromellose, and titanium dioxide. The capsule shell is imprinted with black ink that contains butyl alcohol, dehydrated alcohol, ferric oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution. KOSELUGO (selumetinib) 7.5 mg oral granules contain 7.5 mg selumetinib (equivalent to 9.08 mg selumetinib sulfate). The uncoated cores contain selumetinib sulfate, glyceryl dibehenate, and stearoyl polyoxylglycerides. The granule coating contains acetone, hypromellose acetate succinate, and stearic acid. The capsule shell contains ferric oxide red, hypromellose, and titanium dioxide. The capsule shell is imprinted with black ink that contains butyl alcohol, dehydrated alcohol, ferric oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution."
},
{
"NDCCode": "16590-625-28",
"PackageDescription": "28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16590-625-28)",
"NDC11Code": "16590-0625-28",
"ProductNDC": "16590-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nexium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021153",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "NEXIUM is a proton pump inhibitor indicated for the following: 1 Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 Risk reduction of NSAID-associated gastric ulcer (1.2), 3 H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4 Pathological hypersecretory conditions including Zollinger-Ellison syndrome (1.4).",
"Description": "The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&C Yellow #10. Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration."
},
{
"NDCCode": "21749-625-28",
"PackageDescription": "828 mL in 1 PACKAGE (21749-625-28) ",
"NDC11Code": "21749-0625-28",
"ProductNDC": "21749-625",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purell Advanced Hand Sanitizer Naturals Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "63187-625-28",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (63187-625-28) ",
"NDC11Code": "63187-0625-28",
"ProductNDC": "63187-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065489",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below.",
"Description": "Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.96. The structural formula is. Clarithromycin is a white or almost white, crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water.Clarithromycin tablets, USP are available as immediate-release tablets.Each film-coated tablet contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, hypromellose, titanium dioxide, hydroxypropyl cellulose, iron oxide yellow, propylene glycol, vanillin, and sorbic acid."
},
{
"NDCCode": "69968-0625-1",
"PackageDescription": "1 TUBE in 1 CARTON (69968-0625-1) / 28.3 g in 1 TUBE",
"NDC11Code": "69968-0625-01",
"ProductNDC": "69968-0625",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benadryl Original Strength Itch Stopping",
"NonProprietaryName": "Diphenhydramine Hydrochloride And Zinc Acetate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200131",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE",
"StrengthNumber": "10; 1",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200131",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves pain and itching associated with:. insect bites. minor burns. sunburn. minor skin irritations. minor cuts. scrapes. rashes due to poison ivy, poison oak, and poison sumac. dries the oozing and weeping of poison ivy, poison oak and poison sumac."
},
{
"NDCCode": "70000-0625-1",
"PackageDescription": "1 TUBE in 1 BOX (70000-0625-1) / 28.4 g in 1 TUBE",
"NDC11Code": "70000-0625-01",
"ProductNDC": "70000-0625",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Triple Antibiotic And Pain Relief",
"NonProprietaryName": "Bacitracin,neomycin,polymxin, Pramoxine",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230215",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Cardinal Health 110 dba LEADER",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE",
"StrengthNumber": "500; 3.5; 10; 10000",
"StrengthUnit": "[USP'U]/g; mg/g; mg/g; [USP'U]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2025-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230215",
"SamplePackage": "N",
"IndicationAndUsage": "First Aid to help prevent infection and for temporary relief of pain or discomfort in minor: 1 Cuts, 2 Scrapes, 3 Burns."
},
{
"NDCCode": "71610-625-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (71610-625-28) ",
"NDC11Code": "71610-0625-28",
"ProductNDC": "71610-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100223",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018163",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240614",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules USP should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam Capsules USP are benzodiazepine hypnotic agents. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2 H-1,4-benzodiazepin-2-one, and the structural formula is:. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam Capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration."
},
{
"NDCCode": "0310-0075-01",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0075-01) ",
"NDC11Code": "00310-0075-01",
"ProductNDC": "0310-0075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etcamah",
"NonProprietaryName": "Camizestrant",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260904",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220359",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "CAMIZESTRANT",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260904",
"SamplePackage": "N",
"IndicationAndUsage": "ETCAMAH in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on progression-free survival as measured from detection of ESR1 mutation [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "ETCAMAH tablets contain camizestrant, an estrogen receptor antagonist for oral use. The chemical name is N-[1-(3-fluoropropyl)-3-azetidinyl]-6-[(6S,8R)-8-methyl-7-(2,2,2-trifluoroethyl)-6,7,8,9-tetrahydro-3H-pyrazolo[4,3-f]isoquinolin-6-yl]-3-pyridinamine. Camizestrant is white to brown powder. The molecular formula for camizestrant is C24H28F4N6 and the molecular weight is 476.51 g/mol. The chemical structure for camizestrant is shown below. Each ETCAMAH tablet contains 75 mg camizestrant and the following inactive ingredients: anhydrous dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating consists of ferric oxide red, ferric oxide yellow, ferrosoferric oxide, polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "0310-0088-28",
"PackageDescription": "1 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-28) / 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "00310-0088-28",
"ProductNDC": "0310-0088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daliresp",
"NonProprietaryName": "Roflumilast",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022522",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ROFLUMILAST",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180123",
"SamplePackage": "N",
"IndicationAndUsage": "DALIRESP® is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.",
"Description": "The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is. The drug substance is a white to off-white non-hygroscopic powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. DALIRESP is supplied as white to off-white, round tablets, embossed with “D” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg or 500 mcg of roflumilast. Each tablet of DALIRESP for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, povidone, and magnesium stearate."
},
{
"NDCCode": "0310-0088-95",
"PackageDescription": "1 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-95) > 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "00310-0088-95",
"ProductNDC": "0310-0088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daliresp",
"NonProprietaryName": "Roflumilast",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022522",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ROFLUMILAST",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180123",
"EndMarketingDatePackage": "20230430",
"SamplePackage": "N",
"IndicationAndUsage": "DALIRESP® is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.",
"Description": "The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is. The drug substance is a white to off-white non-hygroscopic powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. DALIRESP is supplied as white to off-white, round tablets, embossed with “D” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg or 500 mcg of roflumilast. Each tablet of DALIRESP for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, povidone, and magnesium stearate."
},
{
"NDCCode": "0310-0512-28",
"PackageDescription": "28 CAPSULE, GELATIN COATED in 1 BOTTLE (0310-0512-28) ",
"NDC11Code": "00310-0512-28",
"ProductNDC": "0310-0512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calquence",
"NonProprietaryName": "Acalabrutinib",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210259",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ACALABRUTINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180401",
"EndMarketingDatePackage": "20210731",
"SamplePackage": "N"
},
{
"NDCCode": "0310-0610-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (0310-0610-28) ",
"NDC11Code": "00310-0610-28",
"ProductNDC": "0310-0610",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Koselugo",
"NonProprietaryName": "Selumetinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213756",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "SELUMETINIB",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210611",
"SamplePackage": "N",
"IndicationAndUsage": "KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2)].",
"Description": "KOSELUGO contains selumetinib sulfate, a kinase inhibitor. The chemical name is 5-[(4-bromo-2-chlorophenyl)amino]-4-fluoro-6-[(2-hydroxyethoxy)carbamoyl]-1-methyl-1H-benzimidazol-3-ium hydrogen sulfate. The molecular formula for selumetinib sulfate is C17H17BrClFN4O7S and the relative molecular mass is 555.76 g/mol. Selumetinib sulfate has the following structural formula. Selumetinib sulfate is a white to yellow monomorphic crystalline powder that exhibits a pH dependent solubility. Selumetinib sulfate is freely soluble at pH < 1.5, sparingly soluble in the pH range at 1.5 to 3 and slightly soluble at pH > 3. Selumetinib sulfate has two ionizable functions with pKa values of 2.8 and 8.4. KOSELUGO (selumetinib) 10 mg capsules for oral use, contain 10 mg selumetinib (equivalent to 12.1 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains carnauba wax, carrageenan, hypromellose, potassium chloride, purified water, and titanium dioxide. The capsule is imprinted with black ink that contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. KOSELUGO (selumetinib) 25 mg capsules for oral use, contain 25 mg selumetinib (equivalent to 30.25 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains carnauba wax and/or cornstarch, carrageenan, FD&C blue 2, ferric oxide yellow, hypromellose, potassium chloride, purified water, and titanium dioxide. The capsule is imprinted with black ink that contains carnauba wax, FD&C Blue 2 aluminum lake, ferric oxide red, ferric oxide yellow, glyceryl monooleate, and shellac. KOSELUGO (selumetinib) 5 mg oral granules contain 5 mg selumetinib (equivalent to 6.05 mg selumetinib sulfate). The uncoated cores contain selumetinib sulfate, glyceryl dibehenate, and stearoyl polyoxylglycerides. The granule coating contains acetone, hypromellose acetate succinate, and stearic acid. The capsule shell contains ferric oxide yellow, hypromellose, and titanium dioxide. The capsule shell is imprinted with black ink that contains butyl alcohol, dehydrated alcohol, ferric oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution. KOSELUGO (selumetinib) 7.5 mg oral granules contain 7.5 mg selumetinib (equivalent to 9.08 mg selumetinib sulfate). The uncoated cores contain selumetinib sulfate, glyceryl dibehenate, and stearoyl polyoxylglycerides. The granule coating contains acetone, hypromellose acetate succinate, and stearic acid. The capsule shell contains ferric oxide red, hypromellose, and titanium dioxide. The capsule shell is imprinted with black ink that contains butyl alcohol, dehydrated alcohol, ferric oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution."
},
{
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"PackageDescription": "28 AEROSOL, METERED in 1 INHALER (0310-4600-28) ",
"NDC11Code": "00310-4600-28",
"ProductNDC": "0310-4600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bevespi Aerosphere",
"NonProprietaryName": "Glycopyrrolate And Formoterol Fumarate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20161003",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208294",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "FORMOTEROL FUMARATE; GLYCOPYRROLATE",
"StrengthNumber": "4.8; 9",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170501",
"SamplePackage": "N"
},
{
"NDCCode": "0310-4600-39",
"PackageDescription": "28 AEROSOL, METERED in 1 INHALER (0310-4600-39) ",
"NDC11Code": "00310-4600-39",
"ProductNDC": "0310-4600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bevespi Aerosphere",
"NonProprietaryName": "Glycopyrrolate And Formoterol Fumarate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20161003",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208294",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "FORMOTEROL FUMARATE; GLYCOPYRROLATE",
"StrengthNumber": "4.8; 9",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170801",
"SamplePackage": "N"
},
{
"NDCCode": "0310-4616-28",
"PackageDescription": "28 AEROSOL, METERED in 1 INHALER (0310-4616-28) ",
"NDC11Code": "00310-4616-28",
"ProductNDC": "0310-4616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breztri",
"NonProprietaryName": "Budesonide, Glycopyrrolate, And Formoterol Fumarate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212122",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL",
"StrengthNumber": "160; 9; 4.8",
"StrengthUnit": "ug/1; ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200723",
"SamplePackage": "Y",
"IndicationAndUsage": "BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).",
"Description": "BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation."
},
{
"NDCCode": "0310-4616-39",
"PackageDescription": "28 AEROSOL, METERED in 1 INHALER (0310-4616-39) ",
"NDC11Code": "00310-4616-39",
"ProductNDC": "0310-4616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breztri",
"NonProprietaryName": "Budesonide, Glycopyrrolate, And Formoterol Fumarate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212122",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL",
"StrengthNumber": "160; 9; 4.8",
"StrengthUnit": "ug/1; ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200723",
"SamplePackage": "N",
"IndicationAndUsage": "BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).",
"Description": "BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation."
},
{
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"PackageDescription": "28 AEROSOL, METERED in 1 INHALER (0310-6616-39) ",
"NDC11Code": "00310-6616-39",
"ProductNDC": "0310-6616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breztri",
"NonProprietaryName": "Budesonide, Glycopyrrolate, And Formoterol Fumarate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20260427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212122",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL",
"StrengthNumber": "160; 18; 4.8",
"StrengthUnit": "ug/1; ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).",
"Description": "BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation."
},
{
"NDCCode": "0310-6616-95",
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"NDC11Code": "00310-6616-95",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breztri",
"NonProprietaryName": "Budesonide, Glycopyrrolate, And Formoterol Fumarate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20260427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212122",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL",
"StrengthNumber": "160; 18; 4.8",
"StrengthUnit": "ug/1; ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20260427",
"SamplePackage": "Y",
"IndicationAndUsage": "BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).",
"Description": "BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation."
},
{
"NDCCode": "0310-9080-28",
"PackageDescription": "1 INHALER in 1 CARTON (0310-9080-28) / 28 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "00310-9080-28",
"ProductNDC": "0310-9080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Airsupra",
"NonProprietaryName": "Albuterol Sulfate And Budesonide",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20231002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214070",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ALBUTEROL SULFATE; BUDESONIDE",
"StrengthNumber": "90; 80",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231002",
"SamplePackage": "Y",
"IndicationAndUsage": "AIRSUPRA is indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older.",
"Description": "AIRSUPRA (albuterol and budesonide) Inhalation Aerosol is a pressurized metered dose inhaler containing a combination of micronized albuterol sulfate, a relatively selective, short-acting beta2-adrenergic agonist and micronized budesonide, a corticosteroid, for oral inhalation. Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. Albuterol sulfate has the following chemical name: USP racemic α1 [(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt). The empirical formula is (C13H21NO3)2H2SO4, and the molecular weight is 576.7. Its structural formula is. Albuterol sulfate is a white to off-white powder that is freely soluble in water, slightly soluble in alcohol and in ether, and practically insoluble in chloroform. It has a LogP of 0.44 at physiological pH. Albuterol has one chiral center and exists as a 1:1 racemic mixture. Budesonide is a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. AIRSUPRA is formulated as a hydrofluoroalkane (HFA-134a) propelled pressurized metered dose inhaler containing 120 inhalations. The canister has an attached dose indicator and is supplied with a white plastic actuator with a frosted clear plastic dust cap tethered to it. After priming, each actuation of AIRSUPRA 90 mcg/80 mcg meters 99 mcg of albuterol and 88 mcg of budesonide from the valve which delivers 90 mcg of albuterol (equivalent to 108 mcg of albuterol sulfate) and 80 mcg of budesonide from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inhalation through the delivery system. AIRSUPRA also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) and calcium chloride. Porous particles and HFA-134a are excipients in the formulation."
},
{
"NDCCode": "43419-310-28",
"PackageDescription": "60 mL in 1 TUBE (43419-310-28)",
"NDC11Code": "43419-0310-28",
"ProductNDC": "43419-310",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amorepacific",
"ProprietaryNameSuffix": "Natural Protector",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100915",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".07; .19; .00025",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-08-09",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "50090-0310-0",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (50090-0310-0) ",
"NDC11Code": "50090-0310-00",
"ProductNDC": "50090-0310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicloxacillin Sodium",
"NonProprietaryName": "Dicloxacillin Sodium",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062286",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DICLOXACILLIN SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N"
},
{
"NDCCode": "59735-310-28",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (59735-310-28) > 28.4 g in 1 BOTTLE, PUMP",
"NDC11Code": "59735-0310-28",
"ProductNDC": "59735-310",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Advanced Dual Complex Fade",
"ProprietaryNameSuffix": "Maximum Strength Plus",
"NonProprietaryName": "Hydroquinone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090225",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part358",
"LabelerName": "Biocosmetic Research Labs",
"SubstanceName": "HYDROQUINONE",
"StrengthNumber": "2",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses. For gradual fading of dark (brownish) spots."
},
{
"NDCCode": "62135-310-28",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-310-28) ",
"NDC11Code": "62135-0310-28",
"ProductNDC": "62135-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076896",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2025-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210413",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections ( 1.1) , 2 Bone and Joint Infections ( 1.2) , 3 Complicated Intra-Abdominal Infections ( 1.3) , 4 Infectious Diarrhea ( 1.4) , 5 Typhoid Fever (Enteric Fever) ( 1.5) , 6 Uncomplicated Cervical and Urethral Gonorrhea ( 1.6) , 7 Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) , 8 Plague in adult and pediatric patients ( 1.8) , 9 Chronic Bacterial Prostatitis ( 1.9) , 10 Lower Respiratory Tract Infections ( 1.10) ◦ Acute Exacerbation of Chronic Bronchitis , 11 Urinary Tract Infections ( 1.11) ◦ Urinary Tract Infections (UTI) ◦ Acute Uncomplicated Cystitis ◦ Complicated UTI and Pyelonephritis in Pediatric Patients , 12 Acute Sinusitis ( 1.12) .",
"Description": "Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin Hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3·HC·H 2O and its chemical structure is as follows:. Ciprofloxacin Tablets, USP film-coated are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide. FDA approved dissolution specifications differs from the USP."
},
{
"NDCCode": "85477-310-28",
"PackageDescription": "28 g in 1 TUBE (85477-310-28) ",
"NDC11Code": "85477-0310-28",
"ProductNDC": "85477-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydravex",
"NonProprietaryName": "Hydravex",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250401",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "2",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250401",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.",
"Description": "Each gram of Hydravex Gel Gel contains 20 mg of hydrocortisone. Inactive ingredients include: Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Hydroxyethyl Cellulose, Methylparaben, PEG-4, Propylene Glycol,Propylparaben. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-, (11β)-] with the molecular formula (C 21H 30O 5) and is represented by the following structural formula:. Its molecular weight is 362.47 and its CAS Registery Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents."
},
{
"NDCCode": "16590-625-15",
"PackageDescription": "15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16590-625-15)",
"NDC11Code": "16590-0625-15",
"ProductNDC": "16590-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nexium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021153",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "NEXIUM is a proton pump inhibitor indicated for the following: 1 Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 Risk reduction of NSAID-associated gastric ulcer (1.2), 3 H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4 Pathological hypersecretory conditions including Zollinger-Ellison syndrome (1.4).",
"Description": "The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&C Yellow #10. Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration."
},
{
"NDCCode": "16590-625-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16590-625-30)",
"NDC11Code": "16590-0625-30",
"ProductNDC": "16590-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nexium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021153",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "NEXIUM is a proton pump inhibitor indicated for the following: 1 Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 Risk reduction of NSAID-associated gastric ulcer (1.2), 3 H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4 Pathological hypersecretory conditions including Zollinger-Ellison syndrome (1.4).",
"Description": "The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&C Yellow #10. Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration."
},
{
"NDCCode": "16590-625-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16590-625-60)",
"NDC11Code": "16590-0625-60",
"ProductNDC": "16590-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nexium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021153",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "NEXIUM is a proton pump inhibitor indicated for the following: 1 Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 Risk reduction of NSAID-associated gastric ulcer (1.2), 3 H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4 Pathological hypersecretory conditions including Zollinger-Ellison syndrome (1.4).",
"Description": "The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&C Yellow #10. Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration."
},
{
"NDCCode": "16714-625-01",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-625-01) ",
"NDC11Code": "16714-0625-01",
"ProductNDC": "16714-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202383",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170620",
"SamplePackage": "N",
"Description": "Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in acetone and in methanol. The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg (yellow), 50 mg (light green), 100 mg (orange), 200 mg (blue), 250 mg (purple) and 300 mg (grey) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: D & C Red# 27 (250 mg), FD&C BLUE No. 2 (200 mg and 250 mg), hypromellose, iron oxide black (50 mg and 300 mg), iron oxide yellow (25 mg, 50 mg and 100 mg), iron oxide red (100 mg), lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 400, talc, titanium dioxide and triethyl citrate. Tablets are printed with edible black ink which contains iron oxide black and shellac glaze. Lamotrigine extended-release tablets, USP contains modified release, erodible matrix as the core. The core tablet is coated with a modified enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of modified-release core and the modified enteric coating are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 2."
},
{
"NDCCode": "42291-625-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (42291-625-01) ",
"NDC11Code": "42291-0625-01",
"ProductNDC": "42291-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mexiletine Hydrochloride",
"NonProprietaryName": "Mexiletine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074377",
"LabelerName": "AvKARE",
"SubstanceName": "MEXILETINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130709",
"SamplePackage": "N",
"IndicationAndUsage": "Mexiletine hydrochloride capsules USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.",
"Description": "Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white to off-white crystalline powder with slightly bitter taste, freely soluble in water and in alcohol. Mexiletine hydrochloride, USP has a pKa of 9.2. The chemical name of mexiletine hydrochloride, USP is 1-methyl-2-(2,6-xylyloxy)ethylamine hydrochloride and its structural formula is. C 11H 17NO HCl M.W. 215.72. Each capsule for oral administration, contains 150 mg, 200 mg, or 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, magnesium stearate and pregelatinized corn starch. The capsule shell contains: FD&C Yellow #6, gelatin and titanium dioxide. The 150 mg capsule also contains: D&C Red #28 and FD&C Blue #1 and the 250 mg capsule also contains: D&C Yellow #10 and FD&C Blue #1. The imprinting ink contains: ammonium hydroxide, black iron oxide, D&C Yellow #10, ethyl alcohol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0310-0625-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (0310-0625-28) </PackageDescription>
<NDC11Code>00310-0625-28</NDC11Code>
<ProductNDC>0310-0625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Koselugo</ProprietaryName>
<NonProprietaryName>Selumetinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213756</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>SELUMETINIB</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>KOSELUGO contains selumetinib sulfate, a kinase inhibitor. The chemical name is 5-[(4-bromo-2-chlorophenyl)amino]-4-fluoro-6-[(2-hydroxyethoxy)carbamoyl]-1-methyl-1H-benzimidazol-3-ium hydrogen sulfate. The molecular formula for selumetinib sulfate is C17H17BrClFN4O7S and the relative molecular mass is 555.76 g/mol. Selumetinib sulfate has the following structural formula. Selumetinib sulfate is a white to yellow monomorphic crystalline powder that exhibits a pH dependent solubility. Selumetinib sulfate is freely soluble at pH < 1.5, sparingly soluble in the pH range at 1.5 to 3 and slightly soluble at pH > 3. Selumetinib sulfate has two ionizable functions with pKa values of 2.8 and 8.4. KOSELUGO (selumetinib) 10 mg capsules for oral use, contain 10 mg selumetinib (equivalent to 12.1 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains carnauba wax, carrageenan, hypromellose, potassium chloride, purified water, and titanium dioxide. The capsule is imprinted with black ink that contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. KOSELUGO (selumetinib) 25 mg capsules for oral use, contain 25 mg selumetinib (equivalent to 30.25 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains carnauba wax and/or cornstarch, carrageenan, FD&C blue 2, ferric oxide yellow, hypromellose, potassium chloride, purified water, and titanium dioxide. The capsule is imprinted with black ink that contains carnauba wax, FD&C Blue 2 aluminum lake, ferric oxide red, ferric oxide yellow, glyceryl monooleate, and shellac. KOSELUGO (selumetinib) 5 mg oral granules contain 5 mg selumetinib (equivalent to 6.05 mg selumetinib sulfate). The uncoated cores contain selumetinib sulfate, glyceryl dibehenate, and stearoyl polyoxylglycerides. The granule coating contains acetone, hypromellose acetate succinate, and stearic acid. The capsule shell contains ferric oxide yellow, hypromellose, and titanium dioxide. The capsule shell is imprinted with black ink that contains butyl alcohol, dehydrated alcohol, ferric oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution. KOSELUGO (selumetinib) 7.5 mg oral granules contain 7.5 mg selumetinib (equivalent to 9.08 mg selumetinib sulfate). The uncoated cores contain selumetinib sulfate, glyceryl dibehenate, and stearoyl polyoxylglycerides. The granule coating contains acetone, hypromellose acetate succinate, and stearic acid. The capsule shell contains ferric oxide red, hypromellose, and titanium dioxide. The capsule shell is imprinted with black ink that contains butyl alcohol, dehydrated alcohol, ferric oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>0310-0625-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0310-0625-60) </PackageDescription>
<NDC11Code>00310-0625-60</NDC11Code>
<ProductNDC>0310-0625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Koselugo</ProprietaryName>
<NonProprietaryName>Selumetinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213756</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>SELUMETINIB</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>KOSELUGO contains selumetinib sulfate, a kinase inhibitor. The chemical name is 5-[(4-bromo-2-chlorophenyl)amino]-4-fluoro-6-[(2-hydroxyethoxy)carbamoyl]-1-methyl-1H-benzimidazol-3-ium hydrogen sulfate. The molecular formula for selumetinib sulfate is C17H17BrClFN4O7S and the relative molecular mass is 555.76 g/mol. Selumetinib sulfate has the following structural formula. Selumetinib sulfate is a white to yellow monomorphic crystalline powder that exhibits a pH dependent solubility. Selumetinib sulfate is freely soluble at pH < 1.5, sparingly soluble in the pH range at 1.5 to 3 and slightly soluble at pH > 3. Selumetinib sulfate has two ionizable functions with pKa values of 2.8 and 8.4. KOSELUGO (selumetinib) 10 mg capsules for oral use, contain 10 mg selumetinib (equivalent to 12.1 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains carnauba wax, carrageenan, hypromellose, potassium chloride, purified water, and titanium dioxide. The capsule is imprinted with black ink that contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. KOSELUGO (selumetinib) 25 mg capsules for oral use, contain 25 mg selumetinib (equivalent to 30.25 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains carnauba wax and/or cornstarch, carrageenan, FD&C blue 2, ferric oxide yellow, hypromellose, potassium chloride, purified water, and titanium dioxide. The capsule is imprinted with black ink that contains carnauba wax, FD&C Blue 2 aluminum lake, ferric oxide red, ferric oxide yellow, glyceryl monooleate, and shellac. KOSELUGO (selumetinib) 5 mg oral granules contain 5 mg selumetinib (equivalent to 6.05 mg selumetinib sulfate). The uncoated cores contain selumetinib sulfate, glyceryl dibehenate, and stearoyl polyoxylglycerides. The granule coating contains acetone, hypromellose acetate succinate, and stearic acid. The capsule shell contains ferric oxide yellow, hypromellose, and titanium dioxide. The capsule shell is imprinted with black ink that contains butyl alcohol, dehydrated alcohol, ferric oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution. KOSELUGO (selumetinib) 7.5 mg oral granules contain 7.5 mg selumetinib (equivalent to 9.08 mg selumetinib sulfate). The uncoated cores contain selumetinib sulfate, glyceryl dibehenate, and stearoyl polyoxylglycerides. The granule coating contains acetone, hypromellose acetate succinate, and stearic acid. The capsule shell contains ferric oxide red, hypromellose, and titanium dioxide. The capsule shell is imprinted with black ink that contains butyl alcohol, dehydrated alcohol, ferric oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>16590-625-28</NDCCode>
<PackageDescription>28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16590-625-28)</PackageDescription>
<NDC11Code>16590-0625-28</NDC11Code>
<ProductNDC>16590-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nexium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021153</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>NEXIUM is a proton pump inhibitor indicated for the following: 1 Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 Risk reduction of NSAID-associated gastric ulcer (1.2), 3 H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4 Pathological hypersecretory conditions including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
<Description>The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&C Yellow #10. Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.</Description>
</NDC>
<NDC>
<NDCCode>21749-625-28</NDCCode>
<PackageDescription>828 mL in 1 PACKAGE (21749-625-28) </PackageDescription>
<NDC11Code>21749-0625-28</NDC11Code>
<ProductNDC>21749-625</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purell Advanced Hand Sanitizer Naturals Gel</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-625-28</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (63187-625-28) </PackageDescription>
<NDC11Code>63187-0625-28</NDC11Code>
<ProductNDC>63187-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clarithromycin</ProprietaryName>
<NonProprietaryName>Clarithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065489</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CLARITHROMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below.</IndicationAndUsage>
<Description>Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.96. The structural formula is. Clarithromycin is a white or almost white, crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water.Clarithromycin tablets, USP are available as immediate-release tablets.Each film-coated tablet contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, hypromellose, titanium dioxide, hydroxypropyl cellulose, iron oxide yellow, propylene glycol, vanillin, and sorbic acid.</Description>
</NDC>
<NDC>
<NDCCode>69968-0625-1</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69968-0625-1) / 28.3 g in 1 TUBE</PackageDescription>
<NDC11Code>69968-0625-01</NDC11Code>
<ProductNDC>69968-0625</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benadryl Original Strength Itch Stopping</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride And Zinc Acetate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200131</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE</SubstanceName>
<StrengthNumber>10; 1</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves pain and itching associated with:. insect bites. minor burns. sunburn. minor skin irritations. minor cuts. scrapes. rashes due to poison ivy, poison oak, and poison sumac. dries the oozing and weeping of poison ivy, poison oak and poison sumac.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70000-0625-1</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (70000-0625-1) / 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>70000-0625-01</NDC11Code>
<ProductNDC>70000-0625</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Triple Antibiotic And Pain Relief</ProprietaryName>
<NonProprietaryName>Bacitracin,neomycin,polymxin, Pramoxine</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M004</ApplicationNumber>
<LabelerName>Cardinal Health 110 dba LEADER</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>500; 3.5; 10; 10000</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; mg/g; [USP'U]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First Aid to help prevent infection and for temporary relief of pain or discomfort in minor: 1 Cuts, 2 Scrapes, 3 Burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-625-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (71610-625-28) </PackageDescription>
<NDC11Code>71610-0625-28</NDC11Code>
<ProductNDC>71610-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100223</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018163</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules USP should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam Capsules USP are benzodiazepine hypnotic agents. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2 H-1,4-benzodiazepin-2-one, and the structural formula is:. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam Capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>0310-0075-01</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0075-01) </PackageDescription>
<NDC11Code>00310-0075-01</NDC11Code>
<ProductNDC>0310-0075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etcamah</ProprietaryName>
<NonProprietaryName>Camizestrant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260904</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220359</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>CAMIZESTRANT</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ETCAMAH in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on progression-free survival as measured from detection of ESR1 mutation [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>ETCAMAH tablets contain camizestrant, an estrogen receptor antagonist for oral use. The chemical name is N-[1-(3-fluoropropyl)-3-azetidinyl]-6-[(6S,8R)-8-methyl-7-(2,2,2-trifluoroethyl)-6,7,8,9-tetrahydro-3H-pyrazolo[4,3-f]isoquinolin-6-yl]-3-pyridinamine. Camizestrant is white to brown powder. The molecular formula for camizestrant is C24H28F4N6 and the molecular weight is 476.51 g/mol. The chemical structure for camizestrant is shown below. Each ETCAMAH tablet contains 75 mg camizestrant and the following inactive ingredients: anhydrous dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating consists of ferric oxide red, ferric oxide yellow, ferrosoferric oxide, polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0310-0088-28</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-28) / 28 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00310-0088-28</NDC11Code>
<ProductNDC>0310-0088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daliresp</ProprietaryName>
<NonProprietaryName>Roflumilast</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022522</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>ROFLUMILAST</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DALIRESP® is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.</IndicationAndUsage>
<Description>The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is. The drug substance is a white to off-white non-hygroscopic powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. DALIRESP is supplied as white to off-white, round tablets, embossed with “D” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg or 500 mcg of roflumilast. Each tablet of DALIRESP for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, povidone, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0310-0088-95</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-95) > 28 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00310-0088-95</NDC11Code>
<ProductNDC>0310-0088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daliresp</ProprietaryName>
<NonProprietaryName>Roflumilast</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022522</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>ROFLUMILAST</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180123</StartMarketingDatePackage>
<EndMarketingDatePackage>20230430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DALIRESP® is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.</IndicationAndUsage>
<Description>The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22. The chemical structure is. The drug substance is a white to off-white non-hygroscopic powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. DALIRESP is supplied as white to off-white, round tablets, embossed with “D” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg or 500 mcg of roflumilast. Each tablet of DALIRESP for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, povidone, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0310-0512-28</NDCCode>
<PackageDescription>28 CAPSULE, GELATIN COATED in 1 BOTTLE (0310-0512-28) </PackageDescription>
<NDC11Code>00310-0512-28</NDC11Code>
<ProductNDC>0310-0512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calquence</ProprietaryName>
<NonProprietaryName>Acalabrutinib</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210259</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>ACALABRUTINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180401</StartMarketingDatePackage>
<EndMarketingDatePackage>20210731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0310-0610-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (0310-0610-28) </PackageDescription>
<NDC11Code>00310-0610-28</NDC11Code>
<ProductNDC>0310-0610</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Koselugo</ProprietaryName>
<NonProprietaryName>Selumetinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213756</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>SELUMETINIB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>KOSELUGO contains selumetinib sulfate, a kinase inhibitor. The chemical name is 5-[(4-bromo-2-chlorophenyl)amino]-4-fluoro-6-[(2-hydroxyethoxy)carbamoyl]-1-methyl-1H-benzimidazol-3-ium hydrogen sulfate. The molecular formula for selumetinib sulfate is C17H17BrClFN4O7S and the relative molecular mass is 555.76 g/mol. Selumetinib sulfate has the following structural formula. Selumetinib sulfate is a white to yellow monomorphic crystalline powder that exhibits a pH dependent solubility. Selumetinib sulfate is freely soluble at pH < 1.5, sparingly soluble in the pH range at 1.5 to 3 and slightly soluble at pH > 3. Selumetinib sulfate has two ionizable functions with pKa values of 2.8 and 8.4. KOSELUGO (selumetinib) 10 mg capsules for oral use, contain 10 mg selumetinib (equivalent to 12.1 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains carnauba wax, carrageenan, hypromellose, potassium chloride, purified water, and titanium dioxide. The capsule is imprinted with black ink that contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. KOSELUGO (selumetinib) 25 mg capsules for oral use, contain 25 mg selumetinib (equivalent to 30.25 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains carnauba wax and/or cornstarch, carrageenan, FD&C blue 2, ferric oxide yellow, hypromellose, potassium chloride, purified water, and titanium dioxide. The capsule is imprinted with black ink that contains carnauba wax, FD&C Blue 2 aluminum lake, ferric oxide red, ferric oxide yellow, glyceryl monooleate, and shellac. KOSELUGO (selumetinib) 5 mg oral granules contain 5 mg selumetinib (equivalent to 6.05 mg selumetinib sulfate). The uncoated cores contain selumetinib sulfate, glyceryl dibehenate, and stearoyl polyoxylglycerides. The granule coating contains acetone, hypromellose acetate succinate, and stearic acid. The capsule shell contains ferric oxide yellow, hypromellose, and titanium dioxide. The capsule shell is imprinted with black ink that contains butyl alcohol, dehydrated alcohol, ferric oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution. KOSELUGO (selumetinib) 7.5 mg oral granules contain 7.5 mg selumetinib (equivalent to 9.08 mg selumetinib sulfate). The uncoated cores contain selumetinib sulfate, glyceryl dibehenate, and stearoyl polyoxylglycerides. The granule coating contains acetone, hypromellose acetate succinate, and stearic acid. The capsule shell contains ferric oxide red, hypromellose, and titanium dioxide. The capsule shell is imprinted with black ink that contains butyl alcohol, dehydrated alcohol, ferric oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>0310-4600-28</NDCCode>
<PackageDescription>28 AEROSOL, METERED in 1 INHALER (0310-4600-28) </PackageDescription>
<NDC11Code>00310-4600-28</NDC11Code>
<ProductNDC>0310-4600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bevespi Aerosphere</ProprietaryName>
<NonProprietaryName>Glycopyrrolate And Formoterol Fumarate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20161003</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208294</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>FORMOTEROL FUMARATE; GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>4.8; 9</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0310-4600-39</NDCCode>
<PackageDescription>28 AEROSOL, METERED in 1 INHALER (0310-4600-39) </PackageDescription>
<NDC11Code>00310-4600-39</NDC11Code>
<ProductNDC>0310-4600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bevespi Aerosphere</ProprietaryName>
<NonProprietaryName>Glycopyrrolate And Formoterol Fumarate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20161003</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208294</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>FORMOTEROL FUMARATE; GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>4.8; 9</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0310-4616-28</NDCCode>
<PackageDescription>28 AEROSOL, METERED in 1 INHALER (0310-4616-28) </PackageDescription>
<NDC11Code>00310-4616-28</NDC11Code>
<ProductNDC>0310-4616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breztri</ProprietaryName>
<NonProprietaryName>Budesonide, Glycopyrrolate, And Formoterol Fumarate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212122</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL</SubstanceName>
<StrengthNumber>160; 9; 4.8</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200723</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).</IndicationAndUsage>
<Description>BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation.</Description>
</NDC>
<NDC>
<NDCCode>0310-4616-39</NDCCode>
<PackageDescription>28 AEROSOL, METERED in 1 INHALER (0310-4616-39) </PackageDescription>
<NDC11Code>00310-4616-39</NDC11Code>
<ProductNDC>0310-4616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breztri</ProprietaryName>
<NonProprietaryName>Budesonide, Glycopyrrolate, And Formoterol Fumarate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212122</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL</SubstanceName>
<StrengthNumber>160; 9; 4.8</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).</IndicationAndUsage>
<Description>BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation.</Description>
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<PackageDescription>28 AEROSOL, METERED in 1 INHALER (0310-6616-39) </PackageDescription>
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<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL</SubstanceName>
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<IndicationAndUsage>BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).</IndicationAndUsage>
<Description>BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation.</Description>
</NDC>
<NDC>
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<PackageDescription>28 AEROSOL, METERED in 1 INHALER (0310-6616-95) </PackageDescription>
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<ProductNDC>0310-6616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breztri</ProprietaryName>
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<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20260427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212122</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL</SubstanceName>
<StrengthNumber>160; 18; 4.8</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260427</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. (1.1), 2 the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. (1.2).</IndicationAndUsage>
<Description>BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] for oral inhalation. Budesonide is a corticosteroid with the following chemical name: (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a white to off-white, powder which is practically insoluble in water. The molecular formula is C25H34O6 and the molecular weight is 430.54. The structural formula is as follows:. Budesonide contains nine chiral centers and is a mixture of the two epimers (22R and 22S). Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is C19H28BrNO3, and the molecular weight is 398.33 g/mol. The structural formula is as follows:. Glycopyrrolate contains two chiral centers and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. Formoterol fumarate has the chemical name N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino] ethyl]phenyl] formamide, (E)-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (C19H24N2O4)2·C4H4O4·2H2O and the molecular weight is 840.91 g/mol. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S). BREZTRI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a yellow plastic actuator and white mouthpiece with a grey dust cap. After priming, each actuation of the inhaler meters 170 mcg of budesonide, 9.6 or 19.1 mcg of glycopyrrolate (equivalent to 7.7 or 15.3 mcg of glycopyrronium), and 5.1 mcg of formoterol fumarate (equivalent to 4.4 mcg of formoterol) from the valve which delivers 160 mcg of budesonide, 9.0 or 18 mcg of glycopyrrolate (equivalent to 7.2 or 14.4 mcg of glycopyrronium), and 4.8 mcg of formoterol fumarate (equivalent to 4.1 mcg of formoterol) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREZTRI AEROSPHERE also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation.</Description>
</NDC>
<NDC>
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<PackageDescription>1 INHALER in 1 CARTON (0310-9080-28) / 28 AEROSOL, METERED in 1 INHALER</PackageDescription>
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<ProductNDC>0310-9080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Airsupra</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate And Budesonide</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20231002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214070</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>ALBUTEROL SULFATE; BUDESONIDE</SubstanceName>
<StrengthNumber>90; 80</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
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<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231002</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>AIRSUPRA is indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older.</IndicationAndUsage>
<Description>AIRSUPRA (albuterol and budesonide) Inhalation Aerosol is a pressurized metered dose inhaler containing a combination of micronized albuterol sulfate, a relatively selective, short-acting beta2-adrenergic agonist and micronized budesonide, a corticosteroid, for oral inhalation. Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. Albuterol sulfate has the following chemical name: USP racemic α1 [(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt). The empirical formula is (C13H21NO3)2H2SO4, and the molecular weight is 576.7. Its structural formula is. Albuterol sulfate is a white to off-white powder that is freely soluble in water, slightly soluble in alcohol and in ether, and practically insoluble in chloroform. It has a LogP of 0.44 at physiological pH. Albuterol has one chiral center and exists as a 1:1 racemic mixture. Budesonide is a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. AIRSUPRA is formulated as a hydrofluoroalkane (HFA-134a) propelled pressurized metered dose inhaler containing 120 inhalations. The canister has an attached dose indicator and is supplied with a white plastic actuator with a frosted clear plastic dust cap tethered to it. After priming, each actuation of AIRSUPRA 90 mcg/80 mcg meters 99 mcg of albuterol and 88 mcg of budesonide from the valve which delivers 90 mcg of albuterol (equivalent to 108 mcg of albuterol sulfate) and 80 mcg of budesonide from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inhalation through the delivery system. AIRSUPRA also contains porous particles that form a co-suspension with the drug crystals. The porous particles are comprised of the phospholipid 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) and calcium chloride. Porous particles and HFA-134a are excipients in the formulation.</Description>
</NDC>
<NDC>
<NDCCode>43419-310-28</NDCCode>
<PackageDescription>60 mL in 1 TUBE (43419-310-28)</PackageDescription>
<NDC11Code>43419-0310-28</NDC11Code>
<ProductNDC>43419-310</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amorepacific</ProprietaryName>
<ProprietaryNameSuffix>Natural Protector</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100915</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>AMOREPACIFIC</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.07; .19; .00025</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-08-09</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-0310-0</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (50090-0310-0) </PackageDescription>
<NDC11Code>50090-0310-00</NDC11Code>
<ProductNDC>50090-0310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicloxacillin Sodium</ProprietaryName>
<NonProprietaryName>Dicloxacillin Sodium</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062286</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DICLOXACILLIN SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59735-310-28</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (59735-310-28) > 28.4 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>59735-0310-28</NDC11Code>
<ProductNDC>59735-310</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Advanced Dual Complex Fade</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength Plus</ProprietaryNameSuffix>
<NonProprietaryName>Hydroquinone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090225</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part358</ApplicationNumber>
<LabelerName>Biocosmetic Research Labs</LabelerName>
<SubstanceName>HYDROQUINONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses. For gradual fading of dark (brownish) spots.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62135-310-28</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-310-28) </PackageDescription>
<NDC11Code>62135-0310-28</NDC11Code>
<ProductNDC>62135-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076896</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections ( 1.1) , 2 Bone and Joint Infections ( 1.2) , 3 Complicated Intra-Abdominal Infections ( 1.3) , 4 Infectious Diarrhea ( 1.4) , 5 Typhoid Fever (Enteric Fever) ( 1.5) , 6 Uncomplicated Cervical and Urethral Gonorrhea ( 1.6) , 7 Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) , 8 Plague in adult and pediatric patients ( 1.8) , 9 Chronic Bacterial Prostatitis ( 1.9) , 10 Lower Respiratory Tract Infections ( 1.10) ◦ Acute Exacerbation of Chronic Bronchitis , 11 Urinary Tract Infections ( 1.11) ◦ Urinary Tract Infections (UTI) ◦ Acute Uncomplicated Cystitis ◦ Complicated UTI and Pyelonephritis in Pediatric Patients , 12 Acute Sinusitis ( 1.12) .</IndicationAndUsage>
<Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin Hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3·HC·H 2O and its chemical structure is as follows:. Ciprofloxacin Tablets, USP film-coated are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide. FDA approved dissolution specifications differs from the USP.</Description>
</NDC>
<NDC>
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<PackageDescription>28 g in 1 TUBE (85477-310-28) </PackageDescription>
<NDC11Code>85477-0310-28</NDC11Code>
<ProductNDC>85477-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydravex</ProprietaryName>
<NonProprietaryName>Hydravex</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.</IndicationAndUsage>
<Description>Each gram of Hydravex Gel Gel contains 20 mg of hydrocortisone. Inactive ingredients include: Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Hydroxyethyl Cellulose, Methylparaben, PEG-4, Propylene Glycol,Propylparaben. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-, (11β)-] with the molecular formula (C 21H 30O 5) and is represented by the following structural formula:. Its molecular weight is 362.47 and its CAS Registery Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.</Description>
</NDC>
<NDC>
<NDCCode>16590-625-15</NDCCode>
<PackageDescription>15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16590-625-15)</PackageDescription>
<NDC11Code>16590-0625-15</NDC11Code>
<ProductNDC>16590-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nexium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021153</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>NEXIUM is a proton pump inhibitor indicated for the following: 1 Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 Risk reduction of NSAID-associated gastric ulcer (1.2), 3 H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4 Pathological hypersecretory conditions including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
<Description>The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&C Yellow #10. Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.</Description>
</NDC>
<NDC>
<NDCCode>16590-625-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16590-625-30)</PackageDescription>
<NDC11Code>16590-0625-30</NDC11Code>
<ProductNDC>16590-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nexium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021153</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>NEXIUM is a proton pump inhibitor indicated for the following: 1 Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 Risk reduction of NSAID-associated gastric ulcer (1.2), 3 H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4 Pathological hypersecretory conditions including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
<Description>The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&C Yellow #10. Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.</Description>
</NDC>
<NDC>
<NDCCode>16590-625-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16590-625-60)</PackageDescription>
<NDC11Code>16590-0625-60</NDC11Code>
<ProductNDC>16590-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nexium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021153</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>NEXIUM is a proton pump inhibitor indicated for the following: 1 Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 Risk reduction of NSAID-associated gastric ulcer (1.2), 3 H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4 Pathological hypersecretory conditions including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
<Description>The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&C Yellow #10. Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.</Description>
</NDC>
<NDC>
<NDCCode>16714-625-01</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-625-01) </PackageDescription>
<NDC11Code>16714-0625-01</NDC11Code>
<ProductNDC>16714-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202383</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in acetone and in methanol. The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg (yellow), 50 mg (light green), 100 mg (orange), 200 mg (blue), 250 mg (purple) and 300 mg (grey) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: D & C Red# 27 (250 mg), FD&C BLUE No. 2 (200 mg and 250 mg), hypromellose, iron oxide black (50 mg and 300 mg), iron oxide yellow (25 mg, 50 mg and 100 mg), iron oxide red (100 mg), lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 400, talc, titanium dioxide and triethyl citrate. Tablets are printed with edible black ink which contains iron oxide black and shellac glaze. Lamotrigine extended-release tablets, USP contains modified release, erodible matrix as the core. The core tablet is coated with a modified enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of modified-release core and the modified enteric coating are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>42291-625-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (42291-625-01) </PackageDescription>
<NDC11Code>42291-0625-01</NDC11Code>
<ProductNDC>42291-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mexiletine Hydrochloride</ProprietaryName>
<NonProprietaryName>Mexiletine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074377</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>MEXILETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mexiletine hydrochloride capsules USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.</IndicationAndUsage>
<Description>Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white to off-white crystalline powder with slightly bitter taste, freely soluble in water and in alcohol. Mexiletine hydrochloride, USP has a pKa of 9.2. The chemical name of mexiletine hydrochloride, USP is 1-methyl-2-(2,6-xylyloxy)ethylamine hydrochloride and its structural formula is. C 11H 17NO HCl M.W. 215.72. Each capsule for oral administration, contains 150 mg, 200 mg, or 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, magnesium stearate and pregelatinized corn starch. The capsule shell contains: FD&C Yellow #6, gelatin and titanium dioxide. The 150 mg capsule also contains: D&C Red #28 and FD&C Blue #1 and the 250 mg capsule also contains: D&C Yellow #10 and FD&C Blue #1. The imprinting ink contains: ammonium hydroxide, black iron oxide, D&C Yellow #10, ethyl alcohol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac.</Description>
</NDC>
</NDCList>