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"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (63545-233-03) ",
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{
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lancome Paris Renergie Lift Multiaction Lifting And Firming For All Skin Types Broad Spectrum Spf 15 Sunscreen",
"NonProprietaryName": "Avobenzone, Octisalate And Octocrylene",
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"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
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"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N"
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{
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tussi Pres",
"NonProprietaryName": "Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide",
"DosageFormName": "SYRUP",
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"ApplicationNumber": "part341",
"LabelerName": "Kramer Novis",
"SubstanceName": "GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
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"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110328",
"SamplePackage": "N"
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{
"NDCCode": "62685-233-04",
"PackageDescription": "1 TUBE in 1 BOX (62685-233-04) / 145 g in 1 TUBE",
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"ProductNDC": "62685-233",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Orbitol Alpine Fresh Fluoride Whitening Toothpaste",
"NonProprietaryName": "Sodium Monofluorophosphate",
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"RouteName": "DENTAL",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "tropical degil cosmetics industries ltd",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": ".8",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210927",
"SamplePackage": "N",
"IndicationAndUsage": "Aids in the prevention of dental cavities."
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{
"NDCCode": "63824-233-04",
"PackageDescription": "4 POWDER, FOR SOLUTION in 1 CARTON (63824-233-04)",
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"ProductNDC": "63824-233",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex",
"ProprietaryNameSuffix": "Fast-max Night Time Cold And Flu",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Reckitt Benckiser LLC",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "64922-233-04",
"PackageDescription": "680 L in 1 CYLINDER (64922-233-04) ",
"NDC11Code": "64922-0233-04",
"ProductNDC": "64922-233",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
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"RouteName": "RESPIRATORY (INHALATION)",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205767",
"LabelerName": "ADF Welding & Medical, Inc.",
"SubstanceName": "OXYGEN",
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"Status": "Active",
"LastUpdate": "2024-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900101",
"SamplePackage": "N"
},
{
"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."
},
{
"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)",
"StartMarketingDate": "20010205",
"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",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010205",
"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."
},
{
"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",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010305",
"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."
},
{
"NDCCode": "0378-8260-93",
"PackageDescription": "30 POUCH in 1 CARTON (0378-8260-93) / 1 PATCH in 1 POUCH (0378-8260-16) / 9 h in 1 PATCH",
"NDC11Code": "00378-8260-93",
"ProductNDC": "0378-8260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate",
"NonProprietaryName": "Methylphenidate",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20220627",
"EndMarketingDate": "20270430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206497",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METHYLPHENIDATE",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/h",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220627",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate transdermal system is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Use. The use of methylphenidate transdermal system is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.8), Use in Specific Populations (8.4)].",
"Description": "Methylphenidate transdermal system is an adhesive-based matrix transdermal system containing methylphenidate that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether. Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C14H19NO2. The structural formula of methylphenidate is. Transdermal System Components. Methylphenidate transdermal system contains methylphenidate in a polyisobutylene adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the transdermal system size and wear time. Methylphenidate transdermal system consists of four layers, as seen in the figure below (cross-section of the transdermal system). Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing and white ink which contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide, (2) a solid matrix drug reservoir of methylphenidate, polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, (3) a skin contact adhesive formulation of polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, and (4) a fluoropolymer-coated polyester protective liner, which is attached to the adhesive surface and must be removed before the transdermal system can be used. The active component of the transdermal system is methylphenidate. The remaining components are pharmacologically inactive. Methylphenidate transdermal systems are packaged with an additional piece of protective film above the system within each pouch. This piece of protective film is removed and discarded at the time of use."
},
{
"NDCCode": "0378-8261-93",
"PackageDescription": "30 POUCH in 1 CARTON (0378-8261-93) / 1 PATCH in 1 POUCH (0378-8261-16) / 9 h in 1 PATCH",
"NDC11Code": "00378-8261-93",
"ProductNDC": "0378-8261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate",
"NonProprietaryName": "Methylphenidate",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20220627",
"EndMarketingDate": "20270430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206497",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METHYLPHENIDATE",
"StrengthNumber": "1.6",
"StrengthUnit": "mg/h",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220627",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate transdermal system is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Use. The use of methylphenidate transdermal system is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.8), Use in Specific Populations (8.4)].",
"Description": "Methylphenidate transdermal system is an adhesive-based matrix transdermal system containing methylphenidate that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether. Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C14H19NO2. The structural formula of methylphenidate is. Transdermal System Components. Methylphenidate transdermal system contains methylphenidate in a polyisobutylene adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the transdermal system size and wear time. Methylphenidate transdermal system consists of four layers, as seen in the figure below (cross-section of the transdermal system). Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing and white ink which contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide, (2) a solid matrix drug reservoir of methylphenidate, polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, (3) a skin contact adhesive formulation of polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, and (4) a fluoropolymer-coated polyester protective liner, which is attached to the adhesive surface and must be removed before the transdermal system can be used. The active component of the transdermal system is methylphenidate. The remaining components are pharmacologically inactive. Methylphenidate transdermal systems are packaged with an additional piece of protective film above the system within each pouch. This piece of protective film is removed and discarded at the time of use."
},
{
"NDCCode": "0378-8262-93",
"PackageDescription": "30 POUCH in 1 CARTON (0378-8262-93) / 1 PATCH in 1 POUCH (0378-8262-16) / 9 h in 1 PATCH",
"NDC11Code": "00378-8262-93",
"ProductNDC": "0378-8262",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate",
"NonProprietaryName": "Methylphenidate",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20220627",
"EndMarketingDate": "20270430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206497",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METHYLPHENIDATE",
"StrengthNumber": "2.2",
"StrengthUnit": "mg/h",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220627",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate transdermal system is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Use. The use of methylphenidate transdermal system is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.8), Use in Specific Populations (8.4)].",
"Description": "Methylphenidate transdermal system is an adhesive-based matrix transdermal system containing methylphenidate that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether. Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C14H19NO2. The structural formula of methylphenidate is. Transdermal System Components. Methylphenidate transdermal system contains methylphenidate in a polyisobutylene adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the transdermal system size and wear time. Methylphenidate transdermal system consists of four layers, as seen in the figure below (cross-section of the transdermal system). Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing and white ink which contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide, (2) a solid matrix drug reservoir of methylphenidate, polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, (3) a skin contact adhesive formulation of polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, and (4) a fluoropolymer-coated polyester protective liner, which is attached to the adhesive surface and must be removed before the transdermal system can be used. The active component of the transdermal system is methylphenidate. The remaining components are pharmacologically inactive. Methylphenidate transdermal systems are packaged with an additional piece of protective film above the system within each pouch. This piece of protective film is removed and discarded at the time of use."
},
{
"NDCCode": "0378-8263-93",
"PackageDescription": "30 POUCH in 1 CARTON (0378-8263-93) / 1 PATCH in 1 POUCH (0378-8263-16) / 9 h in 1 PATCH",
"NDC11Code": "00378-8263-93",
"ProductNDC": "0378-8263",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate",
"NonProprietaryName": "Methylphenidate",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20220627",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206497",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METHYLPHENIDATE",
"StrengthNumber": "3.3",
"StrengthUnit": "mg/h",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220627",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate transdermal system is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Use. The use of methylphenidate transdermal system is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.8), Use in Specific Populations (8.4)].",
"Description": "Methylphenidate transdermal system is an adhesive-based matrix transdermal system containing methylphenidate that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether. Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C14H19NO2. The structural formula of methylphenidate is. Transdermal System Components. Methylphenidate transdermal system contains methylphenidate in a polyisobutylene adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the transdermal system size and wear time. Methylphenidate transdermal system consists of four layers, as seen in the figure below (cross-section of the transdermal system). Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing and white ink which contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide, (2) a solid matrix drug reservoir of methylphenidate, polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, (3) a skin contact adhesive formulation of polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, and (4) a fluoropolymer-coated polyester protective liner, which is attached to the adhesive surface and must be removed before the transdermal system can be used. The active component of the transdermal system is methylphenidate. The remaining components are pharmacologically inactive. Methylphenidate transdermal systems are packaged with an additional piece of protective film above the system within each pouch. This piece of protective film is removed and discarded at the time of use."
},
{
"NDCCode": "14783-233-01",
"PackageDescription": "30 g in 1 TUBE (14783-233-01) ",
"NDC11Code": "14783-0233-01",
"ProductNDC": "14783-233",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15 Medium 7",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "2.44; 6.5; 1.57",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201112",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctorif rash occurs. ."
},
{
"NDCCode": "24478-322-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (24478-322-04) / 120 mL in 1 BOTTLE",
"NDC11Code": "24478-0322-04",
"ProductNDC": "24478-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quillivant",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "SUSPENSION, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202100",
"LabelerName": "NextWave Pharmaceuticals, Inc",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "mg/120mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121001",
"SamplePackage": "N",
"IndicationAndUsage": "QUILLIVANT XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of QUILLIVANT XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "QUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80% extended-release methylphenidate. After reconstitution, QUILLIVANT XR contains in each 1 mL the equivalent of 5 mg of methylphenidate hydrochloride, present as methylphenidate (4.32 mg) complexed with sodium polystyrene sulfonate. Methylphenidate HCl is a central nervous system (CNS) stimulant. The chemical name is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate structure. C14H19NO2 Mol. Wt. 233.31. QUILLIVANT XR also contains the following inactive ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide."
},
{
"NDCCode": "32909-122-07",
"PackageDescription": "12 BOTTLE, PLASTIC in 1 CASE (32909-122-07) / 250 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "32909-0122-07",
"ProductNDC": "32909-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varibar Honey",
"NonProprietaryName": "Barium Sulfate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208143",
"LabelerName": "E-Z-EM Canada Inc",
"SubstanceName": "BARIUM SULFATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180301",
"SamplePackage": "N",
"IndicationAndUsage": "VARIBAR HONEY is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older.",
"Description": "VARIBAR HONEY (barium sulfate) is a radiographic contrast agent that is supplied as an off-white to lightly colored suspension (40% w/v) with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, and the following chemical structure. VARIBAR HONEY has a viscosity of 3000 cPs and contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, starch modified (from corn), xanthan gum, and xylitol."
},
{
"NDCCode": "32909-122-54",
"PackageDescription": "24 TUBE in 1 CASE (32909-122-54) / 30 mL in 1 TUBE",
"NDC11Code": "32909-0122-54",
"ProductNDC": "32909-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varibar Honey",
"NonProprietaryName": "Barium Sulfate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208143",
"LabelerName": "E-Z-EM Canada Inc",
"SubstanceName": "BARIUM SULFATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "VARIBAR HONEY is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older.",
"Description": "VARIBAR HONEY (barium sulfate) is a radiographic contrast agent that is supplied as an off-white to lightly colored suspension (40% w/v) with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, and the following chemical structure. VARIBAR HONEY has a viscosity of 3000 cPs and contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, starch modified (from corn), xanthan gum, and xylitol."
},
{
"NDCCode": "32909-750-03",
"PackageDescription": "24 BOTTLE, PLASTIC in 1 CARTON (32909-750-03) / 176 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "32909-0750-03",
"ProductNDC": "32909-750",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "E-z-paque",
"NonProprietaryName": "Barium Sulfate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20170601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208036",
"LabelerName": "E-Z-EM Canada Inc",
"SubstanceName": "BARIUM SULFATE",
"StrengthNumber": "960",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170601",
"SamplePackage": "N",
"IndicationAndUsage": "E-Z-PAQUE is indicated for use in single contrast radiographic examinations of the esophagus, stomach, duodenum and small bowel to visualize the gastrointestinal tract (GI) in adult and pediatric patients.",
"Description": "E-Z-PAQUE (barium sulfate) is a radiographic contrast agent that is supplied as a fine, white to lightly colored powder for suspension (96 % w/w) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, and the following chemical structure. E-Z-PAQUE contains excipients including: carrageenan, citric acid, natural and artificial natural and artificial strawberry flavor, natural and artificial vanilla flavor, pectin, polysorbate 80, propylene glycol, saccharin sodium, simethicone, sodium citrate, sorbitol, tragacanth and xanthan gum."
},
{
"NDCCode": "32909-764-01",
"PackageDescription": "24 BOTTLE in 1 CARTON (32909-764-01) / 340 g in 1 BOTTLE",
"NDC11Code": "32909-0764-01",
"ProductNDC": "32909-764",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "E-z-hd",
"NonProprietaryName": "Barium Sulfate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20160111",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208036",
"LabelerName": "E-Z-EM Canada Inc",
"SubstanceName": "BARIUM SULFATE",
"StrengthNumber": "980",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160418",
"SamplePackage": "N",
"IndicationAndUsage": "E-Z-HD is indicated for use in double-contrast radiographic examinations of the esophagus, stomach and duodenum to help visualize the gastrointestinal (GI) tract in patients 12 years and older.",
"Description": "E-Z-HD (barium sulfate) is a radiographic contrast agent that is supplied as a fine, white to lightly colored powder for suspension (98 % w/w) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.43 g/mol, a density of 4.5 g/cm3, and the following chemical structure. E-Z-HD contains excipients including: acacia, artificial cherry flavor, artificial strawberry flavor, carrageenan, citric acid, ethyl maltol, polysorbate 80, saccharin sodium, simethicone, sodium citrate, and sorbitol."
},
{
"NDCCode": "32909-777-03",
"PackageDescription": "24 BOTTLE, PLASTIC in 1 CARTON (32909-777-03) > 450 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "32909-0777-03",
"ProductNDC": "32909-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Readi-cat 2 Mochaccino Smoothie",
"NonProprietaryName": "Barium Sulfate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20170327",
"EndMarketingDate": "20220331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208143",
"LabelerName": "E-Z-EM Canada Inc",
"SubstanceName": "BARIUM SULFATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170327",
"EndMarketingDatePackage": "20220331",
"SamplePackage": "N",
"IndicationAndUsage": "READI-CAT 2 and READI-CAT 2 SMOOTHIES are indicated for use in computed tomography (CT) of the abdomen to delineate the gastrointestinal (GI) tract in adult and pediatric patients.",
"Description": "READI-CAT 2 and READI-CAT 2 SMOOTHIE (barium sulfate) are radiographic contrast agents supplied as a suspension (2% w/v) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, and the following chemical structure. READI-CAT 2 products contain excipients including: benzoic acid, citric acid, potassium sorbate, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution, xanthan gum, and purified water. READI-CAT 2 products also contain natural and artificial flavorings including: banana, blueberry, orange, vanilla, chocolate, and coffee flavors."
},
{
"NDCCode": "32909-814-53",
"PackageDescription": "24 BOX in 1 CASE (32909-814-53) > 3 BOTTLE, PLASTIC in 1 BOX > 20 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "32909-0814-53",
"ProductNDC": "32909-814",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tagitol V",
"NonProprietaryName": "Barium Sulfate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20170804",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208143",
"LabelerName": "E-Z-EM Canada Inc",
"SubstanceName": "BARIUM SULFATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170804",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "TAGITOL V is indicated for use in adult patients for use in computed tomography (CT) colonography as a fecal tagging agent.",
"Description": "TAGITOL V (barium sulfate) is a radiographic contrast agent that is supplied as a 40% w/v, off-white to lightly colored, free-flowing, ready-to-use suspension with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol and the following chemical structure. TAGITOL V contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, maltodextrin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum, and xylitol."
},
{
"NDCCode": "47993-233-01",
"PackageDescription": "237 mL in 1 BOTTLE, PUMP (47993-233-01) ",
"NDC11Code": "47993-0233-01",
"ProductNDC": "47993-233",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200417",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "g/112mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200417",
"SamplePackage": "N",
"IndicationAndUsage": "Uses：. Hand sanitizer to help decrease bacteria on the skin. When water, soap & towel are not available. Recommended for repeated use."
},
{
"NDCCode": "50090-0730-0",
"PackageDescription": "1 INHALER in 1 CARTON (50090-0730-0) / 60 POWDER in 1 INHALER",
"NDC11Code": "50090-0730-00",
"ProductNDC": "50090-0730",
"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": "A-S Medication Solutions",
"SubstanceName": "SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE",
"StrengthNumber": "50; 100",
"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": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141128",
"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."
},
{
"NDCCode": "50090-0731-0",
"PackageDescription": "1 INHALER in 1 CARTON (50090-0731-0) / 60 POWDER in 1 INHALER",
"NDC11Code": "50090-0731-00",
"ProductNDC": "50090-0731",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Advair",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20010205",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021077",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE",
"StrengthNumber": "50; 250",
"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": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141128",
"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."
},
{
"NDCCode": "50090-0732-0",
"PackageDescription": "1 INHALER in 1 CARTON (50090-0732-0) / 60 POWDER in 1 INHALER",
"NDC11Code": "50090-0732-00",
"ProductNDC": "50090-0732",
"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": "A-S Medication Solutions",
"SubstanceName": "SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE",
"StrengthNumber": "50; 500",
"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": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141128",
"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."
},
{
"NDCCode": "50181-0018-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (50181-0018-1) ",
"NDC11Code": "50181-0018-01",
"ProductNDC": "50181-0018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mbm 13 Female",
"NonProprietaryName": "Oxytocin, Phytolacca Decandra, Pituitary (suis), Scrophularia Nodosa, Hypothalamus (suis), Calcarea Carbonica, Cumicifuga Racemosa, Lilium Tigrinum, Sulphur, Causticum, Graphites, Kali Phosphoricum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130404",
"EndMarketingDate": "20220331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "The Wellness Center for Research and Education",
"SubstanceName": "BLACK COHOSH; CAUSTICUM; GRAPHITE; LILIUM LANCIFOLIUM WHOLE FLOWERING; OXYTOCIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM PHOSPHATE, DIBASIC; SCROPHULARIA NODOSA; SULFUR; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND, POSTERIOR",
"StrengthNumber": "89; 144; 144; 89; 6; 89; 3; 233; 3; 89; 5; 3",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130404",
"EndMarketingDatePackage": "20220331",
"SamplePackage": "N"
},
{
"NDCCode": "50181-0021-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (50181-0021-1) ",
"NDC11Code": "50181-0021-01",
"ProductNDC": "50181-0021",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mbm 4 Kidney",
"NonProprietaryName": "Kidney (suis), Solidago Virgaurea, Berberis Vulgaris, Carcinosinum, Belladonna, Cicuta Virosa, Nitricum Acidum, Aconitum Napellus, Argentum Nitricum, Arnica Montana,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130102",
"EndMarketingDate": "20251030",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "The Wellness Center",
"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA WHOLE; BERBERIS VULGARIS ROOT BARK; CICUTA VIROSA ROOT; HUMAN BREAST TUMOR CELL; NITRIC ACID; PORK KIDNEY; SILVER NITRATE; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "144; 233; 8; 5; 84; 8; 89; 3; 233; 3",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130102",
"EndMarketingDatePackage": "20251030",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of fear."
}
]
}
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<NDCList>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63545-233-01</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (63545-233-01) </PackageDescription>
<NDC11Code>63545-0233-01</NDC11Code>
<ProductNDC>63545-233</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Artemisia Vulgaris</ProprietaryName>
<NonProprietaryName>Artemisia Vulgaris</NonProprietaryName>
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<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
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<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>63545-233-02</NDCCode>
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<Status>Active</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>63545-233-03</NDCCode>
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<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49967-233-04</NDCCode>
<PackageDescription>2 g in 1 PACKET (49967-233-04) </PackageDescription>
<NDC11Code>49967-0233-04</NDC11Code>
<ProductNDC>49967-233</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lancome Paris Renergie Lift Multiaction Lifting And Firming For All Skin Types Broad Spectrum Spf 15 Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Octisalate And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 50; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52083-233-04</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (52083-233-04) </PackageDescription>
<NDC11Code>52083-0233-04</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tussi Pres</ProprietaryName>
<NonProprietaryName>Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110328</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kramer Novis</LabelerName>
<SubstanceName>GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>200; 5; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62685-233-04</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (62685-233-04) / 145 g in 1 TUBE</PackageDescription>
<NDC11Code>62685-0233-04</NDC11Code>
<ProductNDC>62685-233</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Orbitol Alpine Fresh Fluoride Whitening Toothpaste</ProprietaryName>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20210927</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>tropical degil cosmetics industries ltd</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>.8</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63824-233-04</NDCCode>
<PackageDescription>4 POWDER, FOR SOLUTION in 1 CARTON (63824-233-04)</PackageDescription>
<NDC11Code>63824-0233-04</NDC11Code>
<ProductNDC>63824-233</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucinex</ProprietaryName>
<ProprietaryNameSuffix>Fast-max Night Time Cold And Flu</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140401</StartMarketingDate>
<EndMarketingDate>20161105</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>64922-233-04</NDCCode>
<PackageDescription>680 L in 1 CYLINDER (64922-233-04) </PackageDescription>
<NDC11Code>64922-0233-04</NDC11Code>
<ProductNDC>64922-233</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19900101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205767</ApplicationNumber>
<LabelerName>ADF Welding & Medical, Inc.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</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>0173-0696-04</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>0173-0697-04</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>0378-8260-93</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (0378-8260-93) / 1 PATCH in 1 POUCH (0378-8260-16) / 9 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-8260-93</NDC11Code>
<ProductNDC>0378-8260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate</ProprietaryName>
<NonProprietaryName>Methylphenidate</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20220627</StartMarketingDate>
<EndMarketingDate>20270430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206497</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>mg/h</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220627</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate transdermal system is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Use. The use of methylphenidate transdermal system is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.8), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate transdermal system is an adhesive-based matrix transdermal system containing methylphenidate that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether. Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C14H19NO2. The structural formula of methylphenidate is. Transdermal System Components. Methylphenidate transdermal system contains methylphenidate in a polyisobutylene adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the transdermal system size and wear time. Methylphenidate transdermal system consists of four layers, as seen in the figure below (cross-section of the transdermal system). Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing and white ink which contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide, (2) a solid matrix drug reservoir of methylphenidate, polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, (3) a skin contact adhesive formulation of polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, and (4) a fluoropolymer-coated polyester protective liner, which is attached to the adhesive surface and must be removed before the transdermal system can be used. The active component of the transdermal system is methylphenidate. The remaining components are pharmacologically inactive. Methylphenidate transdermal systems are packaged with an additional piece of protective film above the system within each pouch. This piece of protective film is removed and discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>0378-8261-93</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (0378-8261-93) / 1 PATCH in 1 POUCH (0378-8261-16) / 9 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-8261-93</NDC11Code>
<ProductNDC>0378-8261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate</ProprietaryName>
<NonProprietaryName>Methylphenidate</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20220627</StartMarketingDate>
<EndMarketingDate>20270430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206497</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE</SubstanceName>
<StrengthNumber>1.6</StrengthNumber>
<StrengthUnit>mg/h</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220627</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate transdermal system is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Use. The use of methylphenidate transdermal system is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.8), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate transdermal system is an adhesive-based matrix transdermal system containing methylphenidate that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether. Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C14H19NO2. The structural formula of methylphenidate is. Transdermal System Components. Methylphenidate transdermal system contains methylphenidate in a polyisobutylene adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the transdermal system size and wear time. Methylphenidate transdermal system consists of four layers, as seen in the figure below (cross-section of the transdermal system). Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing and white ink which contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide, (2) a solid matrix drug reservoir of methylphenidate, polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, (3) a skin contact adhesive formulation of polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, and (4) a fluoropolymer-coated polyester protective liner, which is attached to the adhesive surface and must be removed before the transdermal system can be used. The active component of the transdermal system is methylphenidate. The remaining components are pharmacologically inactive. Methylphenidate transdermal systems are packaged with an additional piece of protective film above the system within each pouch. This piece of protective film is removed and discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>0378-8262-93</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (0378-8262-93) / 1 PATCH in 1 POUCH (0378-8262-16) / 9 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-8262-93</NDC11Code>
<ProductNDC>0378-8262</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate</ProprietaryName>
<NonProprietaryName>Methylphenidate</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20220627</StartMarketingDate>
<EndMarketingDate>20270430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206497</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE</SubstanceName>
<StrengthNumber>2.2</StrengthNumber>
<StrengthUnit>mg/h</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220627</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate transdermal system is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Use. The use of methylphenidate transdermal system is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.8), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate transdermal system is an adhesive-based matrix transdermal system containing methylphenidate that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether. Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C14H19NO2. The structural formula of methylphenidate is. Transdermal System Components. Methylphenidate transdermal system contains methylphenidate in a polyisobutylene adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the transdermal system size and wear time. Methylphenidate transdermal system consists of four layers, as seen in the figure below (cross-section of the transdermal system). Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing and white ink which contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide, (2) a solid matrix drug reservoir of methylphenidate, polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, (3) a skin contact adhesive formulation of polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, and (4) a fluoropolymer-coated polyester protective liner, which is attached to the adhesive surface and must be removed before the transdermal system can be used. The active component of the transdermal system is methylphenidate. The remaining components are pharmacologically inactive. Methylphenidate transdermal systems are packaged with an additional piece of protective film above the system within each pouch. This piece of protective film is removed and discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>0378-8263-93</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (0378-8263-93) / 1 PATCH in 1 POUCH (0378-8263-16) / 9 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-8263-93</NDC11Code>
<ProductNDC>0378-8263</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate</ProprietaryName>
<NonProprietaryName>Methylphenidate</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20220627</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206497</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE</SubstanceName>
<StrengthNumber>3.3</StrengthNumber>
<StrengthUnit>mg/h</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220627</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate transdermal system is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Use. The use of methylphenidate transdermal system is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.8), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate transdermal system is an adhesive-based matrix transdermal system containing methylphenidate that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether. Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C14H19NO2. The structural formula of methylphenidate is. Transdermal System Components. Methylphenidate transdermal system contains methylphenidate in a polyisobutylene adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the transdermal system size and wear time. Methylphenidate transdermal system consists of four layers, as seen in the figure below (cross-section of the transdermal system). Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing and white ink which contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide, (2) a solid matrix drug reservoir of methylphenidate, polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, (3) a skin contact adhesive formulation of polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, and (4) a fluoropolymer-coated polyester protective liner, which is attached to the adhesive surface and must be removed before the transdermal system can be used. The active component of the transdermal system is methylphenidate. The remaining components are pharmacologically inactive. Methylphenidate transdermal systems are packaged with an additional piece of protective film above the system within each pouch. This piece of protective film is removed and discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>14783-233-01</NDCCode>
<PackageDescription>30 g in 1 TUBE (14783-233-01) </PackageDescription>
<NDC11Code>14783-0233-01</NDC11Code>
<ProductNDC>14783-233</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15 Medium 7</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>2.44; 6.5; 1.57</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctorif rash occurs. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24478-322-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (24478-322-04) / 120 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>24478-0322-04</NDC11Code>
<ProductNDC>24478-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quillivant</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202100</ApplicationNumber>
<LabelerName>NextWave Pharmaceuticals, Inc</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/120mL</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>QUILLIVANT XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of QUILLIVANT XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>QUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80% extended-release methylphenidate. After reconstitution, QUILLIVANT XR contains in each 1 mL the equivalent of 5 mg of methylphenidate hydrochloride, present as methylphenidate (4.32 mg) complexed with sodium polystyrene sulfonate. Methylphenidate HCl is a central nervous system (CNS) stimulant. The chemical name is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate structure. C14H19NO2 Mol. Wt. 233.31. QUILLIVANT XR also contains the following inactive ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>32909-122-07</NDCCode>
<PackageDescription>12 BOTTLE, PLASTIC in 1 CASE (32909-122-07) / 250 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>32909-0122-07</NDC11Code>
<ProductNDC>32909-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varibar Honey</ProprietaryName>
<NonProprietaryName>Barium Sulfate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208143</ApplicationNumber>
<LabelerName>E-Z-EM Canada Inc</LabelerName>
<SubstanceName>BARIUM SULFATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VARIBAR HONEY is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older.</IndicationAndUsage>
<Description>VARIBAR HONEY (barium sulfate) is a radiographic contrast agent that is supplied as an off-white to lightly colored suspension (40% w/v) with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, and the following chemical structure. VARIBAR HONEY has a viscosity of 3000 cPs and contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, starch modified (from corn), xanthan gum, and xylitol.</Description>
</NDC>
<NDC>
<NDCCode>32909-122-54</NDCCode>
<PackageDescription>24 TUBE in 1 CASE (32909-122-54) / 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>32909-0122-54</NDC11Code>
<ProductNDC>32909-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varibar Honey</ProprietaryName>
<NonProprietaryName>Barium Sulfate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208143</ApplicationNumber>
<LabelerName>E-Z-EM Canada Inc</LabelerName>
<SubstanceName>BARIUM SULFATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VARIBAR HONEY is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older.</IndicationAndUsage>
<Description>VARIBAR HONEY (barium sulfate) is a radiographic contrast agent that is supplied as an off-white to lightly colored suspension (40% w/v) with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, and the following chemical structure. VARIBAR HONEY has a viscosity of 3000 cPs and contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, starch modified (from corn), xanthan gum, and xylitol.</Description>
</NDC>
<NDC>
<NDCCode>32909-750-03</NDCCode>
<PackageDescription>24 BOTTLE, PLASTIC in 1 CARTON (32909-750-03) / 176 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>32909-0750-03</NDC11Code>
<ProductNDC>32909-750</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>E-z-paque</ProprietaryName>
<NonProprietaryName>Barium Sulfate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208036</ApplicationNumber>
<LabelerName>E-Z-EM Canada Inc</LabelerName>
<SubstanceName>BARIUM SULFATE</SubstanceName>
<StrengthNumber>960</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>E-Z-PAQUE is indicated for use in single contrast radiographic examinations of the esophagus, stomach, duodenum and small bowel to visualize the gastrointestinal tract (GI) in adult and pediatric patients.</IndicationAndUsage>
<Description>E-Z-PAQUE (barium sulfate) is a radiographic contrast agent that is supplied as a fine, white to lightly colored powder for suspension (96 % w/w) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, and the following chemical structure. E-Z-PAQUE contains excipients including: carrageenan, citric acid, natural and artificial natural and artificial strawberry flavor, natural and artificial vanilla flavor, pectin, polysorbate 80, propylene glycol, saccharin sodium, simethicone, sodium citrate, sorbitol, tragacanth and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>32909-764-01</NDCCode>
<PackageDescription>24 BOTTLE in 1 CARTON (32909-764-01) / 340 g in 1 BOTTLE</PackageDescription>
<NDC11Code>32909-0764-01</NDC11Code>
<ProductNDC>32909-764</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>E-z-hd</ProprietaryName>
<NonProprietaryName>Barium Sulfate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160111</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208036</ApplicationNumber>
<LabelerName>E-Z-EM Canada Inc</LabelerName>
<SubstanceName>BARIUM SULFATE</SubstanceName>
<StrengthNumber>980</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>E-Z-HD is indicated for use in double-contrast radiographic examinations of the esophagus, stomach and duodenum to help visualize the gastrointestinal (GI) tract in patients 12 years and older.</IndicationAndUsage>
<Description>E-Z-HD (barium sulfate) is a radiographic contrast agent that is supplied as a fine, white to lightly colored powder for suspension (98 % w/w) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.43 g/mol, a density of 4.5 g/cm3, and the following chemical structure. E-Z-HD contains excipients including: acacia, artificial cherry flavor, artificial strawberry flavor, carrageenan, citric acid, ethyl maltol, polysorbate 80, saccharin sodium, simethicone, sodium citrate, and sorbitol.</Description>
</NDC>
<NDC>
<NDCCode>32909-777-03</NDCCode>
<PackageDescription>24 BOTTLE, PLASTIC in 1 CARTON (32909-777-03) > 450 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>32909-0777-03</NDC11Code>
<ProductNDC>32909-777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Readi-cat 2 Mochaccino Smoothie</ProprietaryName>
<NonProprietaryName>Barium Sulfate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170327</StartMarketingDate>
<EndMarketingDate>20220331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208143</ApplicationNumber>
<LabelerName>E-Z-EM Canada Inc</LabelerName>
<SubstanceName>BARIUM SULFATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170327</StartMarketingDatePackage>
<EndMarketingDatePackage>20220331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>READI-CAT 2 and READI-CAT 2 SMOOTHIES are indicated for use in computed tomography (CT) of the abdomen to delineate the gastrointestinal (GI) tract in adult and pediatric patients.</IndicationAndUsage>
<Description>READI-CAT 2 and READI-CAT 2 SMOOTHIE (barium sulfate) are radiographic contrast agents supplied as a suspension (2% w/v) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, and the following chemical structure. READI-CAT 2 products contain excipients including: benzoic acid, citric acid, potassium sorbate, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution, xanthan gum, and purified water. READI-CAT 2 products also contain natural and artificial flavorings including: banana, blueberry, orange, vanilla, chocolate, and coffee flavors.</Description>
</NDC>
<NDC>
<NDCCode>32909-814-53</NDCCode>
<PackageDescription>24 BOX in 1 CASE (32909-814-53) > 3 BOTTLE, PLASTIC in 1 BOX > 20 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>32909-0814-53</NDC11Code>
<ProductNDC>32909-814</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tagitol V</ProprietaryName>
<NonProprietaryName>Barium Sulfate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170804</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208143</ApplicationNumber>
<LabelerName>E-Z-EM Canada Inc</LabelerName>
<SubstanceName>BARIUM SULFATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170804</StartMarketingDatePackage>
<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TAGITOL V is indicated for use in adult patients for use in computed tomography (CT) colonography as a fecal tagging agent.</IndicationAndUsage>
<Description>TAGITOL V (barium sulfate) is a radiographic contrast agent that is supplied as a 40% w/v, off-white to lightly colored, free-flowing, ready-to-use suspension with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol and the following chemical structure. TAGITOL V contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, maltodextrin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum, and xylitol.</Description>
</NDC>
<NDC>
<NDCCode>47993-233-01</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PUMP (47993-233-01) </PackageDescription>
<NDC11Code>47993-0233-01</NDC11Code>
<ProductNDC>47993-233</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200417</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>g/112mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses：. Hand sanitizer to help decrease bacteria on the skin. When water, soap & towel are not available. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-0730-0</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (50090-0730-0) / 60 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>50090-0730-00</NDC11Code>
<ProductNDC>50090-0730</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>A-S Medication Solutions</LabelerName>
<SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50; 100</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>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</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>50090-0731-0</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (50090-0731-0) / 60 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>50090-0731-00</NDC11Code>
<ProductNDC>50090-0731</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>A-S Medication Solutions</LabelerName>
<SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50; 250</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>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</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>50090-0732-0</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (50090-0732-0) / 60 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>50090-0732-00</NDC11Code>
<ProductNDC>50090-0732</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>A-S Medication Solutions</LabelerName>
<SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50; 500</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>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</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>50181-0018-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (50181-0018-1) </PackageDescription>
<NDC11Code>50181-0018-01</NDC11Code>
<ProductNDC>50181-0018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mbm 13 Female</ProprietaryName>
<NonProprietaryName>Oxytocin, Phytolacca Decandra, Pituitary (suis), Scrophularia Nodosa, Hypothalamus (suis), Calcarea Carbonica, Cumicifuga Racemosa, Lilium Tigrinum, Sulphur, Causticum, Graphites, Kali Phosphoricum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130404</StartMarketingDate>
<EndMarketingDate>20220331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>The Wellness Center for Research and Education</LabelerName>
<SubstanceName>BLACK COHOSH; CAUSTICUM; GRAPHITE; LILIUM LANCIFOLIUM WHOLE FLOWERING; OXYTOCIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM PHOSPHATE, DIBASIC; SCROPHULARIA NODOSA; SULFUR; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND, POSTERIOR</SubstanceName>
<StrengthNumber>89; 144; 144; 89; 6; 89; 3; 233; 3; 89; 5; 3</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130404</StartMarketingDatePackage>
<EndMarketingDatePackage>20220331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50181-0021-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (50181-0021-1) </PackageDescription>
<NDC11Code>50181-0021-01</NDC11Code>
<ProductNDC>50181-0021</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mbm 4 Kidney</ProprietaryName>
<NonProprietaryName>Kidney (suis), Solidago Virgaurea, Berberis Vulgaris, Carcinosinum, Belladonna, Cicuta Virosa, Nitricum Acidum, Aconitum Napellus, Argentum Nitricum, Arnica Montana,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130102</StartMarketingDate>
<EndMarketingDate>20251030</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>The Wellness Center</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA WHOLE; BERBERIS VULGARIS ROOT BARK; CICUTA VIROSA ROOT; HUMAN BREAST TUMOR CELL; NITRIC ACID; PORK KIDNEY; SILVER NITRATE; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>144; 233; 8; 5; 84; 8; 89; 3; 233; 3</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130102</StartMarketingDatePackage>
<EndMarketingDatePackage>20251030</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of fear.</IndicationAndUsage>
</NDC>
</NDCList>