{
"NDC": [
{
"NDCCode": "0173-0822-14",
"PackageDescription": "10 BLISTER PACK in 1 BOX (0173-0822-14) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "00173-0822-14",
"ProductNDC": "0173-0822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Staxyn",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20110421",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200179",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "11.85",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110421",
"SamplePackage": "N"
},
{
"NDCCode": "0173-0822-04",
"PackageDescription": "1 BLISTER PACK in 1 BOX (0173-0822-04) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "00173-0822-04",
"ProductNDC": "0173-0822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Staxyn",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20110421",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200179",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "11.85",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20110421",
"SamplePackage": "N"
},
{
"NDCCode": "0173-0822-61",
"PackageDescription": "1 BLISTER PACK in 1 BOX (0173-0822-61) > 2 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "00173-0822-61",
"ProductNDC": "0173-0822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Staxyn",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20110421",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200179",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "11.85",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-02-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20110421",
"EndMarketingDatePackage": "20200228",
"SamplePackage": "N"
},
{
"NDCCode": "0363-0822-34",
"PackageDescription": "1 TUBE in 1 CARTON (0363-0822-34) > 14 g in 1 TUBE",
"NDC11Code": "00363-0822-34",
"ProductNDC": "0363-0822",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Multi Antibiotic With Pain Relief",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20000323",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Walgreen Company",
"SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "3.5; 10000; 10",
"StrengthUnit": "mg/g; [USP'U]/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10135-822-14",
"PackageDescription": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-822-14) ",
"NDC11Code": "10135-0822-14",
"ProductNDC": "10135-822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204805",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine extended-release tablets, is indicated for the treatment of adults with major depressive disorder (MDD) [ seeClinical Studies (14)].",
"Description": "Desvenlafaxine extended-release is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2(free base) and C 16H 25NO 2C 4H 6O 4H 2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine extended-release is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 50 mg tablet and 100 mg tablet consist of hypromellose, hydroxyethyl cellulose, ethyl cellulose, microcrystalline cellulose, magnesium stearate and film coatings, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides."
},
{
"NDCCode": "42497-822-14",
"PackageDescription": "503 g in 1 BOTTLE, PLASTIC (42497-822-14)",
"NDC11Code": "42497-0822-14",
"ProductNDC": "42497-822",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Skin Cleanser 82",
"NonProprietaryName": "Antibacterial Hand Soap",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100304",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Penco Products, Inc.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50090-0822-2",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (50090-0822-2) ",
"NDC11Code": "50090-0822-02",
"ProductNDC": "50090-0822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091568",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: : 1 Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis. , 3 Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis. , 4 Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. , 5 Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species. .",
"Description": "Amoxicillin and clavulanate potassium tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid).Amoxicillin USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium).Inactive Ingredients:Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, surelease clear (aqueous ethyl cellulose dispersion), and titanium dioxide. Each tablet of amoxicillin and clavulanate contains 0.63 mEq potassium."
},
{
"NDCCode": "55289-822-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE, PLASTIC (55289-822-14) ",
"NDC11Code": "55289-0822-14",
"ProductNDC": "55289-822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin Monohydrate/ Macrocrystalline",
"NonProprietaryName": "Nitrofurantoin Monohydrate/macrocrystalline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110525",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020064",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20141204",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin monohydrate/macrocrystals capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin monohydrate/macrocrystals capsules are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin monohydrate/macrocrystals capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin is an antibacterial agent specific for urinary tract infections. The nitrofurantoin monohydrate/macrocrystals capsules brand of nitrofurantoin is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients: Each capsule contains carbomer 934P, corn starch, compressible sugar, D&C Yellow No. 10, edible gray ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, povidone, talc, and titanium dioxide. Meets USP Dissolution Test 8."
},
{
"NDCCode": "55700-822-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (55700-822-14) ",
"NDC11Code": "55700-0822-14",
"ProductNDC": "55700-822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin (monohydrate/macrocrystals)",
"NonProprietaryName": "Nitrofurantoin (monohydrate/macrocrystals)",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077066",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20191119",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin (monohydrate/macrocrystals) is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are hard gelatin capsule shells containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals USP and 75 mg of nitrofurantoin monohydrate USP. The chemical name of nitrofurantoin macrocrystals USP is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate USP is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients. Each capsule contains carbomer 934P, colloidal silicon dioxide, corn starch, compressible sugar, D&C yellow No. 10, edible white ink, FD&C blue No. 1, FD&C red No. 40, gelatin, lactose monohydrate, magnesium stearate, povidone, talc, and titanium dioxide. Meets USP Dissolution Test 5."
},
{
"NDCCode": "71335-0822-8",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (71335-0822-8) ",
"NDC11Code": "71335-0822-08",
"ProductNDC": "71335-0822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200629",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen sodium tablets are indicated for. the relief of the signs and symptoms of. the management of.",
"Description": "Naproxen sodium tablets, USP are nonsteroidal anti-inflammatory drugs and available as light blue color tablets containing 275 mg of naproxen sodium and dark blue color tablets containing 550 mg of naproxen sodium for oral administration. Naproxen sodium is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen sodium is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. It has the following structural formula. Naproxen sodium USP is a white to creamy crystalline powder, freely soluble in water at neutral pH. Each naproxen sodium tablet, USP contains the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2, hypromellose, magnesium stearate, microcrystalline cellulose, PEG 8000, povidone, talc, and titanium dioxide."
},
{
"NDCCode": "0173-0344-14",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0173-0344-14)",
"NDC11Code": "00173-0344-14",
"ProductNDC": "0173-0344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zantac",
"NonProprietaryName": "Ranitidine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19891001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018703",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0173-0695-04",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0695-04) / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0695-04",
"ProductNDC": "0173-0695",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Advair",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20010228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021077",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "100; 50",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010228",
"SamplePackage": "N",
"IndicationAndUsage": "ADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
"Description": "ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of ADVAIR DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of ADVAIR DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. ADVAIR DISKUS is a purple plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through the DISKUS inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through the DISKUS inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through the DISKUS inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
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"StrengthUnit": "ug/1; ug/1",
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{
"NDCCode": "0173-0696-04",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0696-04) / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0696-04",
"ProductNDC": "0173-0696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Advair",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021077",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "250; 50",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-31",
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"IndicationAndUsage": "ADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
"Description": "ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of ADVAIR DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of ADVAIR DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. ADVAIR DISKUS is a purple plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through the DISKUS inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through the DISKUS inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through the DISKUS inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0696-61",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Advair",
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"LabelerName": "GlaxoSmithKline LLC",
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"StrengthUnit": "ug/1; ug/1",
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{
"NDCCode": "0173-0697-04",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0697-04) / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0697-04",
"ProductNDC": "0173-0697",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Advair",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20010305",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021077",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "500; 50",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-31",
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"IndicationAndUsage": "ADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
"Description": "ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of ADVAIR DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of ADVAIR DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. ADVAIR DISKUS is a purple plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through the DISKUS inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through the DISKUS inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through the DISKUS inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Advair",
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"RouteName": "RESPIRATORY (INHALATION)",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021077",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE",
"StrengthNumber": "50; 500",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-29",
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},
{
"NDCCode": "0173-0848-65",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (0173-0848-65)",
"NDC11Code": "00173-0848-65",
"ProductNDC": "0173-0848",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mekinist",
"NonProprietaryName": "Trametinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130617",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204114",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "TRAMETINIB DIMETHYL SULFOXIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-12-11"
},
{
"NDCCode": "0173-0859-14",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0859-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0859-14",
"ProductNDC": "0173-0859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130826",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "100; 25",
"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": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130826",
"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0859-61",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0859-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0859-61",
"ProductNDC": "0173-0859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130826",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "100; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130826",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0874-14",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0874-14) / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0874-14",
"ProductNDC": "0173-0874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arnuity Ellipta",
"NonProprietaryName": "Fluticasone Furoate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140820",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205625",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140820",
"SamplePackage": "N",
"IndicationAndUsage": "ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.",
"Description": "ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0874-61",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0874-61) > 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0874-61",
"ProductNDC": "0173-0874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arnuity Ellipta",
"NonProprietaryName": "Fluticasone Furoate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140820",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205625",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140820",
"SamplePackage": "N"
},
{
"NDCCode": "0173-0876-14",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0876-14) / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0876-14",
"ProductNDC": "0173-0876",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arnuity Ellipta",
"NonProprietaryName": "Fluticasone Furoate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140820",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205625",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140820",
"SamplePackage": "N",
"IndicationAndUsage": "ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.",
"Description": "ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0876-61",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0876-61) > 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0876-61",
"ProductNDC": "0173-0876",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arnuity Ellipta",
"NonProprietaryName": "Fluticasone Furoate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140820",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205625",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140820",
"SamplePackage": "N"
},
{
"NDCCode": "0173-0882-14",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0882-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0882-14",
"ProductNDC": "0173-0882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "200; 25",
"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": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0882-61",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0882-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0882-61",
"ProductNDC": "0173-0882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "200; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0887-14",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0887-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0887-14",
"ProductNDC": "0173-0887",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trelegy Ellipta",
"NonProprietaryName": "Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20170918",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209482",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE",
"StrengthNumber": "100; 62.5; 25",
"StrengthUnit": "ug/1; ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170918",
"SamplePackage": "N",
"IndicationAndUsage": "TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).",
"Description": "TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0887-61",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0887-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0887-61",
"ProductNDC": "0173-0887",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trelegy Ellipta",
"NonProprietaryName": "Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20170918",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209482",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE",
"StrengthNumber": "100; 62.5; 25",
"StrengthUnit": "ug/1; ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170918",
"SamplePackage": "Y",
"IndicationAndUsage": "TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).",
"Description": "TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0893-14",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0893-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0893-14",
"ProductNDC": "0173-0893",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trelegy Ellipta",
"NonProprietaryName": "Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200909",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209482",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE",
"StrengthNumber": "200; 62.5; 25",
"StrengthUnit": "ug/1; ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).",
"Description": "TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trelegy Ellipta",
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"LabelerName": "GlaxoSmithKline LLC",
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"IndicationAndUsage": "TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).",
"Description": "TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
}
]
}
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<ProprietaryName>Multi Antibiotic With Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20000323</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3.5; 10000; 10</StrengthNumber>
<StrengthUnit>mg/g; [USP'U]/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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<NDC11Code>10135-0822-14</NDC11Code>
<ProductNDC>10135-822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204805</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Desvenlafaxine extended-release tablets, is indicated for the treatment of adults with major depressive disorder (MDD) [ seeClinical Studies (14)].</IndicationAndUsage>
<Description>Desvenlafaxine extended-release is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2(free base) and C 16H 25NO 2C 4H 6O 4H 2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine extended-release is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 50 mg tablet and 100 mg tablet consist of hypromellose, hydroxyethyl cellulose, ethyl cellulose, microcrystalline cellulose, magnesium stearate and film coatings, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides.</Description>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Skin Cleanser 82</ProprietaryName>
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<LabelerName>Penco Products, Inc.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
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<ProductNDC>50090-0822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091568</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: : 1 Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis. , 3 Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis. , 4 Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. , 5 Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species. .</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid).Amoxicillin USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium).Inactive Ingredients:Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, surelease clear (aqueous ethyl cellulose dispersion), and titanium dioxide. Each tablet of amoxicillin and clavulanate contains 0.63 mEq potassium.</Description>
</NDC>
<NDC>
<NDCCode>55289-822-14</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE, PLASTIC (55289-822-14) </PackageDescription>
<NDC11Code>55289-0822-14</NDC11Code>
<ProductNDC>55289-822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin Monohydrate/ Macrocrystalline</ProprietaryName>
<NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystalline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110525</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020064</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
<StrengthNumber>25; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin monohydrate/macrocrystals capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin monohydrate/macrocrystals capsules are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin monohydrate/macrocrystals capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin is an antibacterial agent specific for urinary tract infections. The nitrofurantoin monohydrate/macrocrystals capsules brand of nitrofurantoin is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients: Each capsule contains carbomer 934P, corn starch, compressible sugar, D&C Yellow No. 10, edible gray ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, povidone, talc, and titanium dioxide. Meets USP Dissolution Test 8.</Description>
</NDC>
<NDC>
<NDCCode>55700-822-14</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (55700-822-14) </PackageDescription>
<NDC11Code>55700-0822-14</NDC11Code>
<ProductNDC>55700-822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin (monohydrate/macrocrystals)</ProprietaryName>
<NonProprietaryName>Nitrofurantoin (monohydrate/macrocrystals)</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077066</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
<StrengthNumber>25; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin (monohydrate/macrocrystals) is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are hard gelatin capsule shells containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals USP and 75 mg of nitrofurantoin monohydrate USP. The chemical name of nitrofurantoin macrocrystals USP is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate USP is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients. Each capsule contains carbomer 934P, colloidal silicon dioxide, corn starch, compressible sugar, D&C yellow No. 10, edible white ink, FD&C blue No. 1, FD&C red No. 40, gelatin, lactose monohydrate, magnesium stearate, povidone, talc, and titanium dioxide. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>71335-0822-8</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (71335-0822-8) </PackageDescription>
<NDC11Code>71335-0822-08</NDC11Code>
<ProductNDC>71335-0822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200629</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen sodium tablets are indicated for. the relief of the signs and symptoms of. the management of.</IndicationAndUsage>
<Description>Naproxen sodium tablets, USP are nonsteroidal anti-inflammatory drugs and available as light blue color tablets containing 275 mg of naproxen sodium and dark blue color tablets containing 550 mg of naproxen sodium for oral administration. Naproxen sodium is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen sodium is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. It has the following structural formula. Naproxen sodium USP is a white to creamy crystalline powder, freely soluble in water at neutral pH. Each naproxen sodium tablet, USP contains the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2, hypromellose, magnesium stearate, microcrystalline cellulose, PEG 8000, povidone, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0173-0344-14</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0173-0344-14)</PackageDescription>
<NDC11Code>00173-0344-14</NDC11Code>
<ProductNDC>0173-0344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zantac</ProprietaryName>
<NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19891001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018703</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0173-0695-04</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0695-04) / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0695-04</NDC11Code>
<ProductNDC>0173-0695</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Advair</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20010228</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021077</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>100; 50</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>
<Status>Deprecated</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
<Description>ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of ADVAIR DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of ADVAIR DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. ADVAIR DISKUS is a purple plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through the DISKUS inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through the DISKUS inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through the DISKUS inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0695-61</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0695-61) > 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0695-61</NDC11Code>
<ProductNDC>0173-0695</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Advair</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20010228</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021077</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50; 100</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0173-0696-04</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0696-04) / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0696-04</NDC11Code>
<ProductNDC>0173-0696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Advair</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20010205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021077</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>250; 50</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>
<Status>Deprecated</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
<Description>ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of ADVAIR DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of ADVAIR DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. ADVAIR DISKUS is a purple plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through the DISKUS inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through the DISKUS inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through the DISKUS inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0696-61</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0696-61) > 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0696-61</NDC11Code>
<ProductNDC>0173-0696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Advair</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20010205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021077</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50; 250</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0173-0697-04</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0697-04) / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0697-04</NDC11Code>
<ProductNDC>0173-0697</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Advair</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20010305</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021077</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>500; 50</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>
<Status>Deprecated</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
<Description>ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of ADVAIR DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of ADVAIR DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. ADVAIR DISKUS is a purple plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through the DISKUS inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through the DISKUS inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through the DISKUS inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0697-61</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0697-61) > 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0697-61</NDC11Code>
<ProductNDC>0173-0697</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Advair</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20010305</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021077</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50; 500</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0173-0848-65</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (0173-0848-65)</PackageDescription>
<NDC11Code>00173-0848-65</NDC11Code>
<ProductNDC>0173-0848</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mekinist</ProprietaryName>
<NonProprietaryName>Trametinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130617</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204114</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>TRAMETINIB DIMETHYL SULFOXIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>0173-0859-14</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0859-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0859-14</NDC11Code>
<ProductNDC>0173-0859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130826</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>100; 25</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>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0859-61</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0859-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0859-61</NDC11Code>
<ProductNDC>0173-0859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130826</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>100; 25</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>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130826</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0874-14</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0874-14) / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0874-14</NDC11Code>
<ProductNDC>0173-0874</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arnuity Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140820</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205625</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0874-61</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0874-61) > 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0874-61</NDC11Code>
<ProductNDC>0173-0874</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arnuity Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140820</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205625</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0173-0876-14</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0876-14) / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0876-14</NDC11Code>
<ProductNDC>0173-0876</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arnuity Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140820</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205625</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0876-61</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0876-61) > 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0876-61</NDC11Code>
<ProductNDC>0173-0876</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arnuity Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140820</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205625</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0173-0882-14</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0882-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0882-14</NDC11Code>
<ProductNDC>0173-0882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>200; 25</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>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0882-61</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0882-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0882-61</NDC11Code>
<ProductNDC>0173-0882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
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<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>200; 25</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>
<Status>Deprecated</Status>
<LastUpdate>2024-06-07</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0887-14</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0887-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0887-14</NDC11Code>
<ProductNDC>0173-0887</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trelegy Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20170918</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209482</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>100; 62.5; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).</IndicationAndUsage>
<Description>TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0887-61</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0887-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0887-61</NDC11Code>
<ProductNDC>0173-0887</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trelegy Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20170918</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209482</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>100; 62.5; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).</IndicationAndUsage>
<Description>TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0893-14</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0893-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0893-14</NDC11Code>
<ProductNDC>0173-0893</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trelegy Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200909</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209482</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>200; 62.5; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).</IndicationAndUsage>
<Description>TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0893-61</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0893-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0893-61</NDC11Code>
<ProductNDC>0173-0893</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trelegy Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate</NonProprietaryName>
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<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200909</StartMarketingDate>
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<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>200; 62.5; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200909</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).</IndicationAndUsage>
<Description>TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
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