{
"NDC": [
{
"NDCCode": "42858-564-56",
"PackageDescription": "1 BOTTLE in 1 CARTON (42858-564-56) / 56 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "42858-0564-56",
"ProductNDC": "42858-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline Tartrate",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213268",
"LabelerName": "Rhodes Pharmaceuticals L.P.",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250521",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking-cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is an off-white to light fawn powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3∙C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg modified oval shaped, biconvex film-coated tablet that is white to off-white, debossed with \"V05\" on one side and plain on the other side; and a 1 mg modified oval shaped, biconvex film-coated tablet that is light blue, debossed with \"V10\" on one side and plain on the other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: Tablet core: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. Coating: for 1 mg tablets: FD&C Blue No.2-aluminum lake, hypromellose, polyethylene glycol, talc, titanium dioxide, and triacetin. Coating for 0.5 mg tablets: hypromellose, polyethylene glycol, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "42858-563-56",
"PackageDescription": "1 BOTTLE in 1 CARTON (42858-563-56) / 56 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "42858-0563-56",
"ProductNDC": "42858-563",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline Tartrate",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213268",
"LabelerName": "Rhodes Pharmaceuticals L.P.",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250521",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking-cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is an off-white to light fawn powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3∙C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg modified oval shaped, biconvex film-coated tablet that is white to off-white, debossed with \"V05\" on one side and plain on the other side; and a 1 mg modified oval shaped, biconvex film-coated tablet that is light blue, debossed with \"V10\" on one side and plain on the other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: Tablet core: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. Coating: for 1 mg tablets: FD&C Blue No.2-aluminum lake, hypromellose, polyethylene glycol, talc, titanium dioxide, and triacetin. Coating for 0.5 mg tablets: hypromellose, polyethylene glycol, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "42858-562-42",
"PackageDescription": "1 KIT in 1 BOX (42858-562-42) * 11 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42858-564-19) * 42 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42858-563-32) ",
"NDC11Code": "42858-0562-42",
"ProductNDC": "42858-562",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline",
"NonProprietaryName": "Varenicline",
"DosageFormName": "KIT",
"StartMarketingDate": "20250521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213268",
"LabelerName": "Rhodes Pharmaceuticals L.P.",
"Status": "Deprecated",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250521",
"SamplePackage": "N"
},
{
"NDCCode": "0310-0800-39",
"PackageDescription": "1 POUCH in 1 CARTON (0310-0800-39) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER",
"NDC11Code": "00310-0800-39",
"ProductNDC": "0310-0800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tudorza Pressair",
"NonProprietaryName": "Aclidinium Bromide",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150701",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202450",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ACLIDINIUM BROMIDE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150701",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).",
"Description": "TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on in vitro testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time."
},
{
"NDCCode": "0310-0800-60",
"PackageDescription": "1 POUCH in 1 CARTON (0310-0800-60) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER",
"NDC11Code": "00310-0800-60",
"ProductNDC": "0310-0800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tudorza Pressair",
"NonProprietaryName": "Aclidinium Bromide",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150701",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202450",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ACLIDINIUM BROMIDE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150701",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).",
"Description": "TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on in vitro testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time."
},
{
"NDCCode": "0310-0800-95",
"PackageDescription": "1 POUCH in 1 CARTON (0310-0800-95) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER",
"NDC11Code": "00310-0800-95",
"ProductNDC": "0310-0800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tudorza Pressair",
"NonProprietaryName": "Aclidinium Bromide",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150701",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202450",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ACLIDINIUM BROMIDE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150701",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "Y",
"IndicationAndUsage": "TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).",
"Description": "TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on in vitro testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time."
},
{
"NDCCode": "0310-0900-30",
"PackageDescription": "1 POUCH in 1 CARTON (0310-0900-30) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER",
"NDC11Code": "00310-0900-30",
"ProductNDC": "0310-0900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duaklir Pressair",
"NonProprietaryName": "Aclidinium Bromide And Formoterol Fumarate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220817",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210595",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE",
"StrengthNumber": "400; 12",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220817",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "DUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.4)].",
"Description": "DUAKLIR PRESSAIR consists of a dry powder formulation of aclidinium bromide and formoterol fumarate for oral inhalation only. Aclidinium bromide, is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30 NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. Formoterol fumarate, a racemate, is a selective beta2-adrenergic agonist. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1methylethyl]-amino]ethyl]formanilide fumarate dihydrate. The structural formula is. Formoterol fumarate (as a dihydrate) has a molecular weight of 840.91, and its molecular formula is (C19H24N2O4)2 C4H4O42H2O. Formoterol fumarate is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. DUAKLIR PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of DUAKLIR PRESSAIR provides a metered dose of 12 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier, 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium), and 12.0 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.5 mcg of formoterol fumarate anhydrous and 9.8 mcg of formoterol). This results in delivery of 396 mcg of aclidinium bromide (equivalent to 340 mcg of aclidinium) and 11.8 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.3 mcg of formoterol fumarate anhydrous and 9.7 mcg of formoterol) from the mouthpiece, based on in vitro testing at an average flow rate of approximately 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time."
},
{
"NDCCode": "0310-0900-60",
"PackageDescription": "1 POUCH in 1 CARTON (0310-0900-60) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER",
"NDC11Code": "00310-0900-60",
"ProductNDC": "0310-0900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duaklir Pressair",
"NonProprietaryName": "Aclidinium Bromide And Formoterol Fumarate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220817",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210595",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE",
"StrengthNumber": "400; 12",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220817",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "DUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.4)].",
"Description": "DUAKLIR PRESSAIR consists of a dry powder formulation of aclidinium bromide and formoterol fumarate for oral inhalation only. Aclidinium bromide, is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30 NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. Formoterol fumarate, a racemate, is a selective beta2-adrenergic agonist. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1methylethyl]-amino]ethyl]formanilide fumarate dihydrate. The structural formula is. Formoterol fumarate (as a dihydrate) has a molecular weight of 840.91, and its molecular formula is (C19H24N2O4)2 C4H4O42H2O. Formoterol fumarate is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. DUAKLIR PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of DUAKLIR PRESSAIR provides a metered dose of 12 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier, 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium), and 12.0 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.5 mcg of formoterol fumarate anhydrous and 9.8 mcg of formoterol). This results in delivery of 396 mcg of aclidinium bromide (equivalent to 340 mcg of aclidinium) and 11.8 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.3 mcg of formoterol fumarate anhydrous and 9.7 mcg of formoterol) from the mouthpiece, based on in vitro testing at an average flow rate of approximately 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time."
},
{
"NDCCode": "0480-2600-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-2600-56) ",
"NDC11Code": "00480-2600-56",
"ProductNDC": "0480-2600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eltrombopag",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208815",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260917",
"SamplePackage": "N",
"IndicationAndUsage": "Eltrombopag tablets are a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2), 2 in combination with standard immunosuppressive therapy for the first- line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 3 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1- (3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3- biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 50 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are: Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, microcrystalline cellulose, povidone K-30, and sodium starch glycolate type B (potato). Coating and Ink: FD&C Blue No. 2, hypromellose 2910, iron oxide black, polyethylene glycol 400, propylene glycol, and titanium dioxide."
},
{
"NDCCode": "0480-4015-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-4015-56) ",
"NDC11Code": "00480-4015-56",
"ProductNDC": "0480-4015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eltrombopag",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209938",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260917",
"SamplePackage": "N",
"IndicationAndUsage": "Eltrombopag tablets are a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2), 2 in combination with standard immunosuppressive therapy for the first- line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 3 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1- (3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3- biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are: Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, microcrystalline cellulose, povidone K-30, and sodium starch glycolate type B (potato). Coating and Ink: hypromellose 2910, iron oxide black, polyethylene glycol 400, propylene glycol, and titanium dioxide. The 25 mg tablets also contain FD&C Yellow No. 6. The 75 mg tablets also contain iron oxide red."
},
{
"NDCCode": "0480-4031-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-4031-56) ",
"NDC11Code": "00480-4031-56",
"ProductNDC": "0480-4031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eltrombopag",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209938",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260917",
"SamplePackage": "N",
"IndicationAndUsage": "Eltrombopag tablets are a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2), 2 in combination with standard immunosuppressive therapy for the first- line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 3 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1- (3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3- biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are: Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, microcrystalline cellulose, povidone K-30, and sodium starch glycolate type B (potato). Coating and Ink: hypromellose 2910, iron oxide black, polyethylene glycol 400, propylene glycol, and titanium dioxide. The 25 mg tablets also contain FD&C Yellow No. 6. The 75 mg tablets also contain iron oxide red."
},
{
"NDCCode": "0480-4210-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-4210-56) ",
"NDC11Code": "00480-4210-56",
"ProductNDC": "0480-4210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eltrombopag",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209938",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260917",
"SamplePackage": "N",
"IndicationAndUsage": "Eltrombopag tablets are a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2), 2 in combination with standard immunosuppressive therapy for the first- line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 3 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1- (3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3- biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are: Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, microcrystalline cellulose, povidone K-30, and sodium starch glycolate type B (potato). Coating and Ink: hypromellose 2910, iron oxide black, polyethylene glycol 400, propylene glycol, and titanium dioxide. The 25 mg tablets also contain FD&C Yellow No. 6. The 75 mg tablets also contain iron oxide red."
},
{
"NDCCode": "66869-564-30",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (66869-564-30) / 30 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "66869-0564-30",
"ProductNDC": "66869-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seglentis",
"NonProprietaryName": "Celecoxib And Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220101",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213426",
"LabelerName": "Kowa Pharmaceuticals America, Inc.",
"SubstanceName": "CELECOXIB; TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "56; 44",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Full Opioid Agonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220101",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "SEGLENTIS is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "SEGLENTIS (celecoxib and tramadol hydrochloride) tablets contains a co-crystal with molecular weight of 681.2, composed of tramadol hydrochloride, an analgesic and opioid agonist, and celecoxib, a nonsteroidal anti-inflammatory drug, in a 1:1 molecular ratio. The chemical name for tramadol hydrochloride is (1RS,2RS)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride (C16H26ClNO2). The structural formula is. The molecular weight of tramadol hydrochloride is 299.84 (the molecular weight of tramadol is 263.38). The chemical name for celecoxib is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole (C17H14F3N3O2S). The molecular weight is 381.38 and it has the following chemical structure. SEGLENTIS coated tablets contain 56 mg celecoxib and 44 mg of tramadol hydrochloride (equivalent to 39 mg tramadol) in a co-crystal structure. Tablets are white to off-white in color. Inactive ingredients in the tablet are sodium lauryl sulfate, crospovidone, mannitol, sodium stearyl fumarate, talc, cellulose microcrystalline, copovidone and color mixture (polyvinyl alcohol partially hydrolyzed, titanium dioxide, polyethylene glycol and talc)."
},
{
"NDCCode": "66869-564-35",
"PackageDescription": "35 TABLET in 1 BOTTLE, PLASTIC (66869-564-35) ",
"NDC11Code": "66869-0564-35",
"ProductNDC": "66869-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seglentis",
"NonProprietaryName": "Celecoxib And Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220101",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213426",
"LabelerName": "Kowa Pharmaceuticals America, Inc.",
"SubstanceName": "CELECOXIB; TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "56; 44",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Full Opioid Agonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220101",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "SEGLENTIS is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "SEGLENTIS (celecoxib and tramadol hydrochloride) tablets contains a co-crystal with molecular weight of 681.2, composed of tramadol hydrochloride, an analgesic and opioid agonist, and celecoxib, a nonsteroidal anti-inflammatory drug, in a 1:1 molecular ratio. The chemical name for tramadol hydrochloride is (1RS,2RS)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride (C16H26ClNO2). The structural formula is. The molecular weight of tramadol hydrochloride is 299.84 (the molecular weight of tramadol is 263.38). The chemical name for celecoxib is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole (C17H14F3N3O2S). The molecular weight is 381.38 and it has the following chemical structure. SEGLENTIS coated tablets contain 56 mg celecoxib and 44 mg of tramadol hydrochloride (equivalent to 39 mg tramadol) in a co-crystal structure. Tablets are white to off-white in color. Inactive ingredients in the tablet are sodium lauryl sulfate, crospovidone, mannitol, sodium stearyl fumarate, talc, cellulose microcrystalline, copovidone and color mixture (polyvinyl alcohol partially hydrolyzed, titanium dioxide, polyethylene glycol and talc)."
},
{
"NDCCode": "66869-564-90",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (66869-564-90) / 90 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "66869-0564-90",
"ProductNDC": "66869-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seglentis",
"NonProprietaryName": "Celecoxib And Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220101",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213426",
"LabelerName": "Kowa Pharmaceuticals America, Inc.",
"SubstanceName": "CELECOXIB; TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "56; 44",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Full Opioid Agonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220101",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "SEGLENTIS is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "SEGLENTIS (celecoxib and tramadol hydrochloride) tablets contains a co-crystal with molecular weight of 681.2, composed of tramadol hydrochloride, an analgesic and opioid agonist, and celecoxib, a nonsteroidal anti-inflammatory drug, in a 1:1 molecular ratio. The chemical name for tramadol hydrochloride is (1RS,2RS)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride (C16H26ClNO2). The structural formula is. The molecular weight of tramadol hydrochloride is 299.84 (the molecular weight of tramadol is 263.38). The chemical name for celecoxib is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole (C17H14F3N3O2S). The molecular weight is 381.38 and it has the following chemical structure. SEGLENTIS coated tablets contain 56 mg celecoxib and 44 mg of tramadol hydrochloride (equivalent to 39 mg tramadol) in a co-crystal structure. Tablets are white to off-white in color. Inactive ingredients in the tablet are sodium lauryl sulfate, crospovidone, mannitol, sodium stearyl fumarate, talc, cellulose microcrystalline, copovidone and color mixture (polyvinyl alcohol partially hydrolyzed, titanium dioxide, polyethylene glycol and talc)."
},
{
"NDCCode": "70515-001-01",
"PackageDescription": "1 POUCH in 1 CARTON (70515-001-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER",
"NDC11Code": "70515-0001-01",
"ProductNDC": "70515-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duaklir Pressair",
"NonProprietaryName": "Aclidinium Bromide And Formoterol Fumarate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210595",
"LabelerName": "Covis Pharma US, Inc",
"SubstanceName": "ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE",
"StrengthNumber": "400; 12",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N",
"IndicationAndUsage": "DUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.4)].",
"Description": "DUAKLIR PRESSAIR consists of a dry powder formulation of aclidinium bromide and formoterol fumarate for oral inhalation only. Aclidinium bromide, is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30 NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. Formoterol fumarate, a racemate, is a selective beta2-adrenergic agonist. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1methylethyl]-amino]ethyl]formanilide fumarate dihydrate. The structural formula is. Formoterol fumarate (as a dihydrate) has a molecular weight of 840.91, and its molecular formula is (C19H24N2O4)2 C4H4O42H2O. Formoterol fumarate is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. DUAKLIR PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of DUAKLIR PRESSAIR provides a metered dose of 12 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier, 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium), and 12.0 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.5 mcg of formoterol fumarate anhydrous and 9.8 mcg of formoterol). This results in delivery of 396 mcg of aclidinium bromide (equivalent to 340 mcg of aclidinium) and 11.8 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.3 mcg of formoterol fumarate anhydrous and 9.7 mcg of formoterol) from the mouthpiece, based on in vitro testing at an average flow rate of approximately 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time."
},
{
"NDCCode": "70515-001-03",
"PackageDescription": "1 POUCH in 1 CARTON (70515-001-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER",
"NDC11Code": "70515-0001-03",
"ProductNDC": "70515-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duaklir Pressair",
"NonProprietaryName": "Aclidinium Bromide And Formoterol Fumarate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210595",
"LabelerName": "Covis Pharma US, Inc",
"SubstanceName": "ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE",
"StrengthNumber": "400; 12",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N",
"IndicationAndUsage": "DUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.4)].",
"Description": "DUAKLIR PRESSAIR consists of a dry powder formulation of aclidinium bromide and formoterol fumarate for oral inhalation only. Aclidinium bromide, is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30 NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. Formoterol fumarate, a racemate, is a selective beta2-adrenergic agonist. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1methylethyl]-amino]ethyl]formanilide fumarate dihydrate. The structural formula is. Formoterol fumarate (as a dihydrate) has a molecular weight of 840.91, and its molecular formula is (C19H24N2O4)2 C4H4O42H2O. Formoterol fumarate is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. DUAKLIR PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of DUAKLIR PRESSAIR provides a metered dose of 12 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier, 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium), and 12.0 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.5 mcg of formoterol fumarate anhydrous and 9.8 mcg of formoterol). This results in delivery of 396 mcg of aclidinium bromide (equivalent to 340 mcg of aclidinium) and 11.8 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.3 mcg of formoterol fumarate anhydrous and 9.7 mcg of formoterol) from the mouthpiece, based on in vitro testing at an average flow rate of approximately 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time."
},
{
"NDCCode": "70515-002-01",
"PackageDescription": "1 POUCH in 1 CARTON (70515-002-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER",
"NDC11Code": "70515-0002-01",
"ProductNDC": "70515-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tudorza Pressair",
"NonProprietaryName": "Aclidinium Bromide",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202450",
"LabelerName": "Covis Pharma US, Inc",
"SubstanceName": "ACLIDINIUM BROMIDE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150701",
"SamplePackage": "N",
"IndicationAndUsage": "TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).",
"Description": "TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on in vitro testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time."
},
{
"NDCCode": "70515-002-02",
"PackageDescription": "1 POUCH in 1 CARTON (70515-002-02) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER",
"NDC11Code": "70515-0002-02",
"ProductNDC": "70515-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tudorza Pressair",
"NonProprietaryName": "Aclidinium Bromide",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202450",
"LabelerName": "Covis Pharma US, Inc",
"SubstanceName": "ACLIDINIUM BROMIDE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150701",
"SamplePackage": "N",
"IndicationAndUsage": "TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).",
"Description": "TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on in vitro testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time."
},
{
"NDCCode": "70515-002-03",
"PackageDescription": "1 POUCH in 1 CARTON (70515-002-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER",
"NDC11Code": "70515-0002-03",
"ProductNDC": "70515-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tudorza Pressair",
"NonProprietaryName": "Aclidinium Bromide",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202450",
"LabelerName": "Covis Pharma US, Inc",
"SubstanceName": "ACLIDINIUM BROMIDE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150701",
"SamplePackage": "Y",
"IndicationAndUsage": "TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).",
"Description": "TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on in vitro testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time."
},
{
"NDCCode": "42858-001-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (42858-001-01) ",
"NDC11Code": "42858-0001-01",
"ProductNDC": "42858-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091490",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140908",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "42858-001-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (42858-001-10) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "42858-0001-10",
"ProductNDC": "42858-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091490",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140908",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "42858-002-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (42858-002-01) ",
"NDC11Code": "42858-0002-01",
"ProductNDC": "42858-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091490",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140908",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "42858-002-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (42858-002-10) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "42858-0002-10",
"ProductNDC": "42858-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091490",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140908",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "42858-003-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (42858-003-01) ",
"NDC11Code": "42858-0003-01",
"ProductNDC": "42858-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091490",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140908",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "42858-004-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (42858-004-01) ",
"NDC11Code": "42858-0004-01",
"ProductNDC": "42858-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091490",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140908",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "42858-005-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (42858-005-01) ",
"NDC11Code": "42858-0005-01",
"ProductNDC": "42858-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091490",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140908",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "42858-008-06",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-008-06)",
"NDC11Code": "42858-0008-06",
"ProductNDC": "42858-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Palladone",
"NonProprietaryName": "Hydromorphone Hcl",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040924",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021044",
"LabelerName": "Rhodes Pharmaceuticals L.P.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2014-09-12"
},
{
"NDCCode": "42858-008-12",
"PackageDescription": "1 BOX, UNIT-DOSE in 1 BLISTER PACK (42858-008-12) > 20 CAPSULE, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (42858-008-11)",
"NDC11Code": "42858-0008-12",
"ProductNDC": "42858-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Palladone",
"NonProprietaryName": "Hydromorphone Hcl",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040924",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021044",
"LabelerName": "Rhodes Pharmaceuticals L.P.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2014-09-12"
},
{
"NDCCode": "42858-010-15",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (42858-010-15) / 30 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "42858-0010-15",
"ProductNDC": "42858-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205853",
"LabelerName": "Rhodes Pharmaceuticals L.P.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults.",
"Description": "Oxycodone Hydrochloride Oral Solution is an agonist, available as a clear pale yellow liquid 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution,100 mg per 5 mL (20 mg per mL), include purified water, sorbitol solution, anhydrous citric acid, saccharin sodium, sodium citrate, sodium benzoate, D&C Yellow No. 10."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>42858-564-56</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (42858-564-56) / 56 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>42858-0564-56</NDC11Code>
<ProductNDC>42858-564</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline Tartrate</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213268</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals L.P.</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking-cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is an off-white to light fawn powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3∙C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg modified oval shaped, biconvex film-coated tablet that is white to off-white, debossed with "V05" on one side and plain on the other side; and a 1 mg modified oval shaped, biconvex film-coated tablet that is light blue, debossed with "V10" on one side and plain on the other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: Tablet core: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. Coating: for 1 mg tablets: FD&C Blue No.2-aluminum lake, hypromellose, polyethylene glycol, talc, titanium dioxide, and triacetin. Coating for 0.5 mg tablets: hypromellose, polyethylene glycol, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>42858-563-56</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (42858-563-56) / 56 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>42858-0563-56</NDC11Code>
<ProductNDC>42858-563</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline Tartrate</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213268</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals L.P.</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking-cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is an off-white to light fawn powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3∙C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg modified oval shaped, biconvex film-coated tablet that is white to off-white, debossed with "V05" on one side and plain on the other side; and a 1 mg modified oval shaped, biconvex film-coated tablet that is light blue, debossed with "V10" on one side and plain on the other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: Tablet core: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. Coating: for 1 mg tablets: FD&C Blue No.2-aluminum lake, hypromellose, polyethylene glycol, talc, titanium dioxide, and triacetin. Coating for 0.5 mg tablets: hypromellose, polyethylene glycol, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>42858-562-42</NDCCode>
<PackageDescription>1 KIT in 1 BOX (42858-562-42) * 11 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42858-564-19) * 42 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42858-563-32) </PackageDescription>
<NDC11Code>42858-0562-42</NDC11Code>
<ProductNDC>42858-562</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline</ProprietaryName>
<NonProprietaryName>Varenicline</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213268</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals L.P.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0310-0800-39</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0310-0800-39) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>00310-0800-39</NDC11Code>
<ProductNDC>0310-0800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tudorza Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202450</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).</IndicationAndUsage>
<Description>TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on in vitro testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time.</Description>
</NDC>
<NDC>
<NDCCode>0310-0800-60</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0310-0800-60) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>00310-0800-60</NDC11Code>
<ProductNDC>0310-0800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tudorza Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202450</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).</IndicationAndUsage>
<Description>TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on in vitro testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time.</Description>
</NDC>
<NDC>
<NDCCode>0310-0800-95</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0310-0800-95) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>00310-0800-95</NDC11Code>
<ProductNDC>0310-0800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tudorza Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202450</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).</IndicationAndUsage>
<Description>TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on in vitro testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time.</Description>
</NDC>
<NDC>
<NDCCode>0310-0900-30</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0310-0900-30) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>00310-0900-30</NDC11Code>
<ProductNDC>0310-0900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duaklir Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide And Formoterol Fumarate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220817</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210595</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>400; 12</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220817</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.4)].</IndicationAndUsage>
<Description>DUAKLIR PRESSAIR consists of a dry powder formulation of aclidinium bromide and formoterol fumarate for oral inhalation only. Aclidinium bromide, is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30 NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. Formoterol fumarate, a racemate, is a selective beta2-adrenergic agonist. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1methylethyl]-amino]ethyl]formanilide fumarate dihydrate. The structural formula is. Formoterol fumarate (as a dihydrate) has a molecular weight of 840.91, and its molecular formula is (C19H24N2O4)2 C4H4O42H2O. Formoterol fumarate is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. DUAKLIR PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of DUAKLIR PRESSAIR provides a metered dose of 12 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier, 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium), and 12.0 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.5 mcg of formoterol fumarate anhydrous and 9.8 mcg of formoterol). This results in delivery of 396 mcg of aclidinium bromide (equivalent to 340 mcg of aclidinium) and 11.8 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.3 mcg of formoterol fumarate anhydrous and 9.7 mcg of formoterol) from the mouthpiece, based on in vitro testing at an average flow rate of approximately 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time.</Description>
</NDC>
<NDC>
<NDCCode>0310-0900-60</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0310-0900-60) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>00310-0900-60</NDC11Code>
<ProductNDC>0310-0900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duaklir Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide And Formoterol Fumarate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220817</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210595</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>400; 12</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220817</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.4)].</IndicationAndUsage>
<Description>DUAKLIR PRESSAIR consists of a dry powder formulation of aclidinium bromide and formoterol fumarate for oral inhalation only. Aclidinium bromide, is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30 NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. Formoterol fumarate, a racemate, is a selective beta2-adrenergic agonist. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1methylethyl]-amino]ethyl]formanilide fumarate dihydrate. The structural formula is. Formoterol fumarate (as a dihydrate) has a molecular weight of 840.91, and its molecular formula is (C19H24N2O4)2 C4H4O42H2O. Formoterol fumarate is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. DUAKLIR PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of DUAKLIR PRESSAIR provides a metered dose of 12 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier, 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium), and 12.0 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.5 mcg of formoterol fumarate anhydrous and 9.8 mcg of formoterol). This results in delivery of 396 mcg of aclidinium bromide (equivalent to 340 mcg of aclidinium) and 11.8 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.3 mcg of formoterol fumarate anhydrous and 9.7 mcg of formoterol) from the mouthpiece, based on in vitro testing at an average flow rate of approximately 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time.</Description>
</NDC>
<NDC>
<NDCCode>0480-2600-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-2600-56) </PackageDescription>
<NDC11Code>00480-2600-56</NDC11Code>
<ProductNDC>0480-2600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eltrombopag</ProprietaryName>
<NonProprietaryName>Eltrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208815</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Eltrombopag tablets are a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2), 2 in combination with standard immunosuppressive therapy for the first- line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 3 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1- (3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3- biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 50 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are: Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, microcrystalline cellulose, povidone K-30, and sodium starch glycolate type B (potato). Coating and Ink: FD&C Blue No. 2, hypromellose 2910, iron oxide black, polyethylene glycol 400, propylene glycol, and titanium dioxide.</Description>
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<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
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<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2026-09-19</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eltrombopag tablets are a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2), 2 in combination with standard immunosuppressive therapy for the first- line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 3 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1- (3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3- biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are: Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, microcrystalline cellulose, povidone K-30, and sodium starch glycolate type B (potato). Coating and Ink: hypromellose 2910, iron oxide black, polyethylene glycol 400, propylene glycol, and titanium dioxide. The 25 mg tablets also contain FD&C Yellow No. 6. The 75 mg tablets also contain iron oxide red.</Description>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2026-09-19</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eltrombopag tablets are a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2), 2 in combination with standard immunosuppressive therapy for the first- line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 3 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1- (3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3- biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are: Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, microcrystalline cellulose, povidone K-30, and sodium starch glycolate type B (potato). Coating and Ink: hypromellose 2910, iron oxide black, polyethylene glycol 400, propylene glycol, and titanium dioxide. The 25 mg tablets also contain FD&C Yellow No. 6. The 75 mg tablets also contain iron oxide red.</Description>
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<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
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<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eltrombopag tablets are a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2), 2 in combination with standard immunosuppressive therapy for the first- line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 3 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1- (3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3- biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are: Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, microcrystalline cellulose, povidone K-30, and sodium starch glycolate type B (potato). Coating and Ink: hypromellose 2910, iron oxide black, polyethylene glycol 400, propylene glycol, and titanium dioxide. The 25 mg tablets also contain FD&C Yellow No. 6. The 75 mg tablets also contain iron oxide red.</Description>
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<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66869-564-30) / 30 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Seglentis</ProprietaryName>
<NonProprietaryName>Celecoxib And Tramadol Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213426</ApplicationNumber>
<LabelerName>Kowa Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>CELECOXIB; TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>56; 44</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Full Opioid Agonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEGLENTIS is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>SEGLENTIS (celecoxib and tramadol hydrochloride) tablets contains a co-crystal with molecular weight of 681.2, composed of tramadol hydrochloride, an analgesic and opioid agonist, and celecoxib, a nonsteroidal anti-inflammatory drug, in a 1:1 molecular ratio. The chemical name for tramadol hydrochloride is (1RS,2RS)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride (C16H26ClNO2). The structural formula is. The molecular weight of tramadol hydrochloride is 299.84 (the molecular weight of tramadol is 263.38). The chemical name for celecoxib is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole (C17H14F3N3O2S). The molecular weight is 381.38 and it has the following chemical structure. SEGLENTIS coated tablets contain 56 mg celecoxib and 44 mg of tramadol hydrochloride (equivalent to 39 mg tramadol) in a co-crystal structure. Tablets are white to off-white in color. Inactive ingredients in the tablet are sodium lauryl sulfate, crospovidone, mannitol, sodium stearyl fumarate, talc, cellulose microcrystalline, copovidone and color mixture (polyvinyl alcohol partially hydrolyzed, titanium dioxide, polyethylene glycol and talc).</Description>
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<NDCCode>66869-564-35</NDCCode>
<PackageDescription>35 TABLET in 1 BOTTLE, PLASTIC (66869-564-35) </PackageDescription>
<NDC11Code>66869-0564-35</NDC11Code>
<ProductNDC>66869-564</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Seglentis</ProprietaryName>
<NonProprietaryName>Celecoxib And Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
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<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213426</ApplicationNumber>
<LabelerName>Kowa Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>CELECOXIB; TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>56; 44</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Full Opioid Agonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEGLENTIS is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>SEGLENTIS (celecoxib and tramadol hydrochloride) tablets contains a co-crystal with molecular weight of 681.2, composed of tramadol hydrochloride, an analgesic and opioid agonist, and celecoxib, a nonsteroidal anti-inflammatory drug, in a 1:1 molecular ratio. The chemical name for tramadol hydrochloride is (1RS,2RS)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride (C16H26ClNO2). The structural formula is. The molecular weight of tramadol hydrochloride is 299.84 (the molecular weight of tramadol is 263.38). The chemical name for celecoxib is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole (C17H14F3N3O2S). The molecular weight is 381.38 and it has the following chemical structure. SEGLENTIS coated tablets contain 56 mg celecoxib and 44 mg of tramadol hydrochloride (equivalent to 39 mg tramadol) in a co-crystal structure. Tablets are white to off-white in color. Inactive ingredients in the tablet are sodium lauryl sulfate, crospovidone, mannitol, sodium stearyl fumarate, talc, cellulose microcrystalline, copovidone and color mixture (polyvinyl alcohol partially hydrolyzed, titanium dioxide, polyethylene glycol and talc).</Description>
</NDC>
<NDC>
<NDCCode>66869-564-90</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66869-564-90) / 90 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66869-0564-90</NDC11Code>
<ProductNDC>66869-564</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Seglentis</ProprietaryName>
<NonProprietaryName>Celecoxib And Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213426</ApplicationNumber>
<LabelerName>Kowa Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>CELECOXIB; TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>56; 44</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Full Opioid Agonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEGLENTIS is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>SEGLENTIS (celecoxib and tramadol hydrochloride) tablets contains a co-crystal with molecular weight of 681.2, composed of tramadol hydrochloride, an analgesic and opioid agonist, and celecoxib, a nonsteroidal anti-inflammatory drug, in a 1:1 molecular ratio. The chemical name for tramadol hydrochloride is (1RS,2RS)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride (C16H26ClNO2). The structural formula is. The molecular weight of tramadol hydrochloride is 299.84 (the molecular weight of tramadol is 263.38). The chemical name for celecoxib is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole (C17H14F3N3O2S). The molecular weight is 381.38 and it has the following chemical structure. SEGLENTIS coated tablets contain 56 mg celecoxib and 44 mg of tramadol hydrochloride (equivalent to 39 mg tramadol) in a co-crystal structure. Tablets are white to off-white in color. Inactive ingredients in the tablet are sodium lauryl sulfate, crospovidone, mannitol, sodium stearyl fumarate, talc, cellulose microcrystalline, copovidone and color mixture (polyvinyl alcohol partially hydrolyzed, titanium dioxide, polyethylene glycol and talc).</Description>
</NDC>
<NDC>
<NDCCode>70515-001-01</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (70515-001-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>70515-0001-01</NDC11Code>
<ProductNDC>70515-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duaklir Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide And Formoterol Fumarate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210595</ApplicationNumber>
<LabelerName>Covis Pharma US, Inc</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>400; 12</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.4)].</IndicationAndUsage>
<Description>DUAKLIR PRESSAIR consists of a dry powder formulation of aclidinium bromide and formoterol fumarate for oral inhalation only. Aclidinium bromide, is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30 NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. Formoterol fumarate, a racemate, is a selective beta2-adrenergic agonist. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1methylethyl]-amino]ethyl]formanilide fumarate dihydrate. The structural formula is. Formoterol fumarate (as a dihydrate) has a molecular weight of 840.91, and its molecular formula is (C19H24N2O4)2 C4H4O42H2O. Formoterol fumarate is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. DUAKLIR PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of DUAKLIR PRESSAIR provides a metered dose of 12 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier, 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium), and 12.0 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.5 mcg of formoterol fumarate anhydrous and 9.8 mcg of formoterol). This results in delivery of 396 mcg of aclidinium bromide (equivalent to 340 mcg of aclidinium) and 11.8 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.3 mcg of formoterol fumarate anhydrous and 9.7 mcg of formoterol) from the mouthpiece, based on in vitro testing at an average flow rate of approximately 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time.</Description>
</NDC>
<NDC>
<NDCCode>70515-001-03</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (70515-001-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>70515-0001-03</NDC11Code>
<ProductNDC>70515-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duaklir Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide And Formoterol Fumarate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210595</ApplicationNumber>
<LabelerName>Covis Pharma US, Inc</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>400; 12</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.4)].</IndicationAndUsage>
<Description>DUAKLIR PRESSAIR consists of a dry powder formulation of aclidinium bromide and formoterol fumarate for oral inhalation only. Aclidinium bromide, is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30 NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. Formoterol fumarate, a racemate, is a selective beta2-adrenergic agonist. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1methylethyl]-amino]ethyl]formanilide fumarate dihydrate. The structural formula is. Formoterol fumarate (as a dihydrate) has a molecular weight of 840.91, and its molecular formula is (C19H24N2O4)2 C4H4O42H2O. Formoterol fumarate is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. DUAKLIR PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of DUAKLIR PRESSAIR provides a metered dose of 12 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier, 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium), and 12.0 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.5 mcg of formoterol fumarate anhydrous and 9.8 mcg of formoterol). This results in delivery of 396 mcg of aclidinium bromide (equivalent to 340 mcg of aclidinium) and 11.8 mcg of formoterol fumarate (as a dihydrate, equivalent to 11.3 mcg of formoterol fumarate anhydrous and 9.7 mcg of formoterol) from the mouthpiece, based on in vitro testing at an average flow rate of approximately 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time.</Description>
</NDC>
<NDC>
<NDCCode>70515-002-01</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (70515-002-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>70515-0002-01</NDC11Code>
<ProductNDC>70515-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tudorza Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202450</ApplicationNumber>
<LabelerName>Covis Pharma US, Inc</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).</IndicationAndUsage>
<Description>TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on in vitro testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time.</Description>
</NDC>
<NDC>
<NDCCode>70515-002-02</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (70515-002-02) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>70515-0002-02</NDC11Code>
<ProductNDC>70515-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tudorza Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202450</ApplicationNumber>
<LabelerName>Covis Pharma US, Inc</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).</IndicationAndUsage>
<Description>TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on in vitro testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time.</Description>
</NDC>
<NDC>
<NDCCode>70515-002-03</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (70515-002-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>70515-0002-03</NDC11Code>
<ProductNDC>70515-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tudorza Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202450</ApplicationNumber>
<LabelerName>Covis Pharma US, Inc</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).</IndicationAndUsage>
<Description>TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3R)-. The structural formula is. Aclidinium bromide is a white powder with a molecular formula of C26H30NO4S2Br and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on in vitro testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time.</Description>
</NDC>
<NDC>
<NDCCode>42858-001-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (42858-001-01) </PackageDescription>
<NDC11Code>42858-0001-01</NDC11Code>
<ProductNDC>42858-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091490</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>42858-001-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (42858-001-10) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42858-0001-10</NDC11Code>
<ProductNDC>42858-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091490</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>42858-002-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (42858-002-01) </PackageDescription>
<NDC11Code>42858-0002-01</NDC11Code>
<ProductNDC>42858-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091490</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>42858-002-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (42858-002-10) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42858-0002-10</NDC11Code>
<ProductNDC>42858-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091490</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>42858-003-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (42858-003-01) </PackageDescription>
<NDC11Code>42858-0003-01</NDC11Code>
<ProductNDC>42858-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091490</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>42858-004-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (42858-004-01) </PackageDescription>
<NDC11Code>42858-0004-01</NDC11Code>
<ProductNDC>42858-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091490</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>42858-005-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (42858-005-01) </PackageDescription>
<NDC11Code>42858-0005-01</NDC11Code>
<ProductNDC>42858-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091490</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. C18H21NO4∙HCl MW 351.82. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>42858-008-06</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-008-06)</PackageDescription>
<NDC11Code>42858-0008-06</NDC11Code>
<ProductNDC>42858-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Palladone</ProprietaryName>
<NonProprietaryName>Hydromorphone Hcl</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040924</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021044</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals L.P.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-09-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>42858-008-12</NDCCode>
<PackageDescription>1 BOX, UNIT-DOSE in 1 BLISTER PACK (42858-008-12) > 20 CAPSULE, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (42858-008-11)</PackageDescription>
<NDC11Code>42858-0008-12</NDC11Code>
<ProductNDC>42858-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Palladone</ProprietaryName>
<NonProprietaryName>Hydromorphone Hcl</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040924</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021044</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals L.P.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-09-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>42858-010-15</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (42858-010-15) / 30 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>42858-0010-15</NDC11Code>
<ProductNDC>42858-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205853</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals L.P.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Oral Solution is an agonist, available as a clear pale yellow liquid 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution,100 mg per 5 mL (20 mg per mL), include purified water, sorbitol solution, anhydrous citric acid, saccharin sodium, sodium citrate, sodium benzoate, D&C Yellow No. 10.</Description>
</NDC>
</NDCList>