{
"NDC": [
{
"NDCCode": "66302-014-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BOX (66302-014-01) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "66302-0014-01",
"ProductNDC": "66302-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Unituxin",
"NonProprietaryName": "Dinutuximab",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150310",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125516",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "DINUTUXIMAB",
"StrengthNumber": "3.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Glycolipid Disialoganglioside-directed Antibody Interactions [MoA], Glycolipid Disialoganglioside-directed Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150310",
"SamplePackage": "N",
"IndicationAndUsage": "Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14)].",
"Description": "Dinutuximab is a glycolipid disialoganglioside (GD2)-binding chimeric monoclonal antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG1 and light chain kappa. Dinutuximab is produced in the murine myeloma cell line, SP2/0 and has an approximate molecular weight of 150 kDa. Unituxin (dinutuximab) injection is a sterile, preservative-free, clear and colorless to slightly opalescent solution for intravenous infusion. Unituxin is supplied in single-dose vials of 17.5 mg/5 mL. Each mL of solution contains 3.5 mg of dinutuximab, and histidine (3.10 mg), polysorbate 20 (0.55 mg), sodium chloride (8.77 mg), and Water for Injection, USP; hydrochloric acid is added to adjust pH to 6.8."
},
{
"NDCCode": "66302-101-01",
"PackageDescription": "1 VIAL in 1 BOX (66302-101-01) / 20 mL in 1 VIAL",
"NDC11Code": "66302-0101-01",
"ProductNDC": "66302-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Remodulin",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20020522",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021272",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020522",
"SamplePackage": "N",
"IndicationAndUsage": "Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).",
"Description": "Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection."
},
{
"NDCCode": "66302-102-01",
"PackageDescription": "1 VIAL in 1 BOX (66302-102-01) / 20 mL in 1 VIAL",
"NDC11Code": "66302-0102-01",
"ProductNDC": "66302-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Remodulin",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20020522",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021272",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020522",
"SamplePackage": "N",
"IndicationAndUsage": "Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).",
"Description": "Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection."
},
{
"NDCCode": "66302-105-01",
"PackageDescription": "1 VIAL in 1 BOX (66302-105-01) / 20 mL in 1 VIAL",
"NDC11Code": "66302-0105-01",
"ProductNDC": "66302-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Remodulin",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20020522",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021272",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "100",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020522",
"SamplePackage": "N",
"IndicationAndUsage": "Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).",
"Description": "Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection."
},
{
"NDCCode": "66302-110-01",
"PackageDescription": "1 VIAL in 1 BOX (66302-110-01) / 20 mL in 1 VIAL",
"NDC11Code": "66302-0110-01",
"ProductNDC": "66302-110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Remodulin",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20020522",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021272",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "200",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020522",
"SamplePackage": "N",
"IndicationAndUsage": "Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).",
"Description": "Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection."
},
{
"NDCCode": "66302-111-01",
"PackageDescription": "1 VIAL in 1 BOX (66302-111-01) / 20 mL in 1 VIAL",
"NDC11Code": "66302-0111-01",
"ProductNDC": "66302-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Remodulin",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021272",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "2",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N",
"IndicationAndUsage": "Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).",
"Description": "Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection."
},
{
"NDCCode": "66302-112-01",
"PackageDescription": "1 VIAL in 1 BOX (66302-112-01) / 20 mL in 1 VIAL",
"NDC11Code": "66302-0112-01",
"ProductNDC": "66302-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Remodulin",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021272",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "4",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N",
"IndicationAndUsage": "Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).",
"Description": "Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection."
},
{
"NDCCode": "66302-114-01",
"PackageDescription": "1 VIAL in 1 BOX (66302-114-01) / 20 mL in 1 VIAL",
"NDC11Code": "66302-0114-01",
"ProductNDC": "66302-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Remodulin",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021272",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "8",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N",
"IndicationAndUsage": "Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).",
"Description": "Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection."
},
{
"NDCCode": "66302-120-01",
"PackageDescription": "1 VIAL in 1 BOX (66302-120-01) / 20 mL in 1 VIAL",
"NDC11Code": "66302-0120-01",
"ProductNDC": "66302-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Remodulin",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20220125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021272",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "400",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220125",
"SamplePackage": "N",
"IndicationAndUsage": "Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).",
"Description": "Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection."
},
{
"NDCCode": "66302-206-01",
"PackageDescription": "1 BOX in 1 KIT (66302-206-01) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE",
"NDC11Code": "66302-0206-01",
"ProductNDC": "66302-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tyvaso",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INHALANT",
"RouteName": "ORAL",
"StartMarketingDate": "20090814",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022387",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "1.74",
"StrengthUnit": "mg/2.9mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090814",
"SamplePackage": "N",
"IndicationAndUsage": "Tyvaso is a prostacyclin mimetic indicated for the treatment of: 1 Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). (1.1), 2 Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). (1.2).",
"Description": "Tyvaso is a sterile formulation of treprostinil, a prostacyclin mimetic, intended for administration by oral inhalation using the Tyvaso Inhalation System. Tyvaso is supplied in 2.9 mL low density polyethylene (LDPE) ampules, containing 1.74 mg treprostinil (0.6 mg/mL). Each ampule also contains 18.9 mg sodium chloride, 18.3 mg sodium citrate dihydrate, 0.58 mg sodium hydroxide, 11.7 mg 1 N hydrochloric acid, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is."
},
{
"NDCCode": "66302-300-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-300-01) ",
"NDC11Code": "66302-0300-01",
"ProductNDC": "66302-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orenitram",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203496",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131220",
"SamplePackage": "N",
"IndicationAndUsage": "Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 To delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%). (1.1).",
"Description": "Orenitram is an extended-release osmotic tablet for oral administration. Orenitram is formulated as the diolamine salt of treprostinil, a tricyclic benzindene analogue of prostacyclin. The chemical name is Acetic acid, 2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]-, complexed with 2,2'-iminobis[ethanol] (1:1). The molecular formula is C23H34O5∙C4H11NO2, the molecular weight is 495.65, and it has the following structural formula. Orenitram tablets are formulated in five strengths, which contain 0.125 mg of treprostinil (equivalent to 0.159 mg treprostinil diolamine), 0.25 mg of treprostinil (equivalent to 0.317 mg treprostinil diolamine), 1 mg of treprostinil (equivalent to 1.27 mg treprostinil diolamine), 2.5 mg of treprostinil (equivalent to 3.17 mg treprostinil diolamine), or 5 mg of treprostinil (equivalent to 6.35 mg treprostinil diolamine). The formulations also contain xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol USP, iron oxide black, n-butyl alcohol, and propylene glycol. Orenitram is designed to release treprostinil at a near zero-order rate using an osmotic tablet technology. The tablet core is coated with a semi-permeable membrane and has a laser-drilled aperture through the membrane. Upon contact with water (e.g., after ingestion), the core tablet absorbs water through the semi-permeable membrane. The water dissolves the water-soluble treprostinil diolamine and the water-soluble osmotic excipients, which creates hydrostatic pressure within the membrane, eventually forcing the drug across the membrane at a controlled rate."
},
{
"NDCCode": "66302-302-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-302-01) ",
"NDC11Code": "66302-0302-01",
"ProductNDC": "66302-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orenitram",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203496",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131220",
"SamplePackage": "N",
"IndicationAndUsage": "Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 To delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%). (1.1).",
"Description": "Orenitram is an extended-release osmotic tablet for oral administration. Orenitram is formulated as the diolamine salt of treprostinil, a tricyclic benzindene analogue of prostacyclin. The chemical name is Acetic acid, 2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]-, complexed with 2,2'-iminobis[ethanol] (1:1). The molecular formula is C23H34O5∙C4H11NO2, the molecular weight is 495.65, and it has the following structural formula. Orenitram tablets are formulated in five strengths, which contain 0.125 mg of treprostinil (equivalent to 0.159 mg treprostinil diolamine), 0.25 mg of treprostinil (equivalent to 0.317 mg treprostinil diolamine), 1 mg of treprostinil (equivalent to 1.27 mg treprostinil diolamine), 2.5 mg of treprostinil (equivalent to 3.17 mg treprostinil diolamine), or 5 mg of treprostinil (equivalent to 6.35 mg treprostinil diolamine). The formulations also contain xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol USP, iron oxide black, n-butyl alcohol, and propylene glycol. Orenitram is designed to release treprostinil at a near zero-order rate using an osmotic tablet technology. The tablet core is coated with a semi-permeable membrane and has a laser-drilled aperture through the membrane. Upon contact with water (e.g., after ingestion), the core tablet absorbs water through the semi-permeable membrane. The water dissolves the water-soluble treprostinil diolamine and the water-soluble osmotic excipients, which creates hydrostatic pressure within the membrane, eventually forcing the drug across the membrane at a controlled rate."
},
{
"NDCCode": "66302-310-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-310-01) ",
"NDC11Code": "66302-0310-01",
"ProductNDC": "66302-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orenitram",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203496",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131220",
"SamplePackage": "N",
"IndicationAndUsage": "Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 To delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%). (1.1).",
"Description": "Orenitram is an extended-release osmotic tablet for oral administration. Orenitram is formulated as the diolamine salt of treprostinil, a tricyclic benzindene analogue of prostacyclin. The chemical name is Acetic acid, 2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]-, complexed with 2,2'-iminobis[ethanol] (1:1). The molecular formula is C23H34O5∙C4H11NO2, the molecular weight is 495.65, and it has the following structural formula. Orenitram tablets are formulated in five strengths, which contain 0.125 mg of treprostinil (equivalent to 0.159 mg treprostinil diolamine), 0.25 mg of treprostinil (equivalent to 0.317 mg treprostinil diolamine), 1 mg of treprostinil (equivalent to 1.27 mg treprostinil diolamine), 2.5 mg of treprostinil (equivalent to 3.17 mg treprostinil diolamine), or 5 mg of treprostinil (equivalent to 6.35 mg treprostinil diolamine). The formulations also contain xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol USP, iron oxide black, n-butyl alcohol, and propylene glycol. Orenitram is designed to release treprostinil at a near zero-order rate using an osmotic tablet technology. The tablet core is coated with a semi-permeable membrane and has a laser-drilled aperture through the membrane. Upon contact with water (e.g., after ingestion), the core tablet absorbs water through the semi-permeable membrane. The water dissolves the water-soluble treprostinil diolamine and the water-soluble osmotic excipients, which creates hydrostatic pressure within the membrane, eventually forcing the drug across the membrane at a controlled rate."
},
{
"NDCCode": "66302-325-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-325-01) ",
"NDC11Code": "66302-0325-01",
"ProductNDC": "66302-325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orenitram",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203496",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131220",
"SamplePackage": "N",
"IndicationAndUsage": "Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 To delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%). (1.1).",
"Description": "Orenitram is an extended-release osmotic tablet for oral administration. Orenitram is formulated as the diolamine salt of treprostinil, a tricyclic benzindene analogue of prostacyclin. The chemical name is Acetic acid, 2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]-, complexed with 2,2'-iminobis[ethanol] (1:1). The molecular formula is C23H34O5∙C4H11NO2, the molecular weight is 495.65, and it has the following structural formula. Orenitram tablets are formulated in five strengths, which contain 0.125 mg of treprostinil (equivalent to 0.159 mg treprostinil diolamine), 0.25 mg of treprostinil (equivalent to 0.317 mg treprostinil diolamine), 1 mg of treprostinil (equivalent to 1.27 mg treprostinil diolamine), 2.5 mg of treprostinil (equivalent to 3.17 mg treprostinil diolamine), or 5 mg of treprostinil (equivalent to 6.35 mg treprostinil diolamine). The formulations also contain xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol USP, iron oxide black, n-butyl alcohol, and propylene glycol. Orenitram is designed to release treprostinil at a near zero-order rate using an osmotic tablet technology. The tablet core is coated with a semi-permeable membrane and has a laser-drilled aperture through the membrane. Upon contact with water (e.g., after ingestion), the core tablet absorbs water through the semi-permeable membrane. The water dissolves the water-soluble treprostinil diolamine and the water-soluble osmotic excipients, which creates hydrostatic pressure within the membrane, eventually forcing the drug across the membrane at a controlled rate."
},
{
"NDCCode": "66302-350-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-350-01) ",
"NDC11Code": "66302-0350-01",
"ProductNDC": "66302-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orenitram",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203496",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131220",
"SamplePackage": "N",
"IndicationAndUsage": "Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 To delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%). (1.1).",
"Description": "Orenitram is an extended-release osmotic tablet for oral administration. Orenitram is formulated as the diolamine salt of treprostinil, a tricyclic benzindene analogue of prostacyclin. The chemical name is Acetic acid, 2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]-, complexed with 2,2'-iminobis[ethanol] (1:1). The molecular formula is C23H34O5∙C4H11NO2, the molecular weight is 495.65, and it has the following structural formula. Orenitram tablets are formulated in five strengths, which contain 0.125 mg of treprostinil (equivalent to 0.159 mg treprostinil diolamine), 0.25 mg of treprostinil (equivalent to 0.317 mg treprostinil diolamine), 1 mg of treprostinil (equivalent to 1.27 mg treprostinil diolamine), 2.5 mg of treprostinil (equivalent to 3.17 mg treprostinil diolamine), or 5 mg of treprostinil (equivalent to 6.35 mg treprostinil diolamine). The formulations also contain xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol USP, iron oxide black, n-butyl alcohol, and propylene glycol. Orenitram is designed to release treprostinil at a near zero-order rate using an osmotic tablet technology. The tablet core is coated with a semi-permeable membrane and has a laser-drilled aperture through the membrane. Upon contact with water (e.g., after ingestion), the core tablet absorbs water through the semi-permeable membrane. The water dissolves the water-soluble treprostinil diolamine and the water-soluble osmotic excipients, which creates hydrostatic pressure within the membrane, eventually forcing the drug across the membrane at a controlled rate."
},
{
"NDCCode": "10348-014-01",
"PackageDescription": "1 TUBE in 1 CARTON (10348-014-01) > 30 mL in 1 TUBE",
"NDC11Code": "10348-0014-01",
"ProductNDC": "10348-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Camera Ready",
"ProprietaryNameSuffix": "Cc Broad Spectrum Spf 30",
"NonProprietaryName": "Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SMASHBOX BEAUTY COSMETICS, INC",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": ".08175; .0436; .02725; .0119",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130201",
"SamplePackage": "N"
},
{
"NDCCode": "10702-014-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (10702-014-01) ",
"NDC11Code": "10702-0014-01",
"ProductNDC": "10702-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betaxolol Hydrochloride",
"NonProprietaryName": "Betaxolol Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078962",
"LabelerName": "KVK-TECH, INC.",
"SubstanceName": "BETAXOLOL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111102",
"SamplePackage": "N",
"IndicationAndUsage": "Betaxolol tablets, USP is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics.",
"Description": "Betaxolol hydrochloride is a ß 1-selective (cardioselective) adrenergic receptor blocking agent available as 10-mg and 20-mg tablets for oral administration. Betaxolol hydrochloride is chemically described as 2-propanol, 1- [4-[2-(cyclopropylmethoxy) ethyl] phenoxy]-3-[(1-methylethyl) amino]-, hydrochloride, (±)-. It has the following chemical structure:. Each tablet for oral administration contains 10 mg or 20 mg of betaxolol hydrochloride equivalent to 8.94 mg or 17.88 mg of betaxolol respectively. In addition, each tablet contains the following inactive ingredients, hypromellose, anhydrous lactose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, stearic acid and titanium dioxide. Betaxolol hydrochloride is a water-soluble white crystalline powder with a molecular formula of C 18H 29NO 3HCl and a molecular weight of 343.9. It is freely soluble in water, ethanol, chloroform, and methanol, and has a pKa of 9.4."
},
{
"NDCCode": "10736-014-01",
"PackageDescription": "988 L in 1 CYLINDER (10736-014-01) ",
"NDC11Code": "10736-0014-01",
"ProductNDC": "10736-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbon Dioxide",
"NonProprietaryName": "Carbon Dioxide",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19630101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206025",
"LabelerName": "MEDICAL-TECHNICAL GASES, INC.",
"SubstanceName": "CARBON DIOXIDE",
"StrengthNumber": "995",
"StrengthUnit": "mL/L",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19630101",
"SamplePackage": "N"
},
{
"NDCCode": "10812-014-01",
"PackageDescription": "124 mL in 1 TUBE (10812-014-01) ",
"NDC11Code": "10812-0014-01",
"ProductNDC": "10812-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Naturals Acne Foaming Scrub",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121101",
"EndMarketingDate": "20210325",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121101",
"EndMarketingDatePackage": "20210325",
"SamplePackage": "N"
},
{
"NDCCode": "10956-014-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (10956-014-01) > 50 TABLET in 1 BOTTLE, PLASTIC (10956-014-50) ",
"NDC11Code": "10956-0014-01",
"ProductNDC": "10956-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Care One Chest Congestion Relief",
"ProprietaryNameSuffix": "Dm",
"NonProprietaryName": "Dextromethorphan Hydrobromide / Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091207",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Reese Pharmaceutical Co",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 400",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110117",
"SamplePackage": "N"
},
{
"NDCCode": "11559-014-01",
"PackageDescription": "1 JAR in 1 CARTON (11559-014-01) > 11 g in 1 JAR (11559-014-02)",
"NDC11Code": "11559-0014-01",
"ProductNDC": "11559-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Double Wear",
"ProprietaryNameSuffix": "Mineral Rich Loose Powder Makeup Spf 12",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ESTEE LAUDER INC",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "2.2",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "13107-014-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13107-014-01) ",
"NDC11Code": "13107-0014-01",
"ProductNDC": "13107-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202675",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230228",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.",
"Description": "Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is:. Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg, as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate."
},
{
"NDCCode": "13733-014-01",
"PackageDescription": "50 mL in 1 CARTON (13733-014-01)",
"NDC11Code": "13733-0014-01",
"ProductNDC": "13733-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missha All Around Safe Block Essence Sun",
"ProprietaryNameSuffix": "Spf45 Pa Plus Plus Plus",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ABLE C&C CO., LTD.",
"SubstanceName": "OCTINOXATE; OCTISALATE; ENSULIZOLE",
"StrengthNumber": "3.5; 2.4; 2",
"StrengthUnit": "mL/50mL; mL/50mL; mL/50mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "INDICATION AND USAGE:- At the last step of basic skin care, apply an appropriate amount evenly over the face. Pat lightly until fully absorbed. - Apply evenly onto the face, neck, arms and legs where sun exposure occurs.- Reapply during long exposure."
},
{
"NDCCode": "14141-014-01",
"PackageDescription": "1 CASE in 1 BOX (14141-014-01) > 9 g in 1 CASE",
"NDC11Code": "14141-0014-01",
"ProductNDC": "14141-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 300-n",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A.",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "75; 78.4",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "14445-014-01",
"PackageDescription": ".1 kg in 1 DRUM (14445-014-01) ",
"NDC11Code": "14445-0014-01",
"ProductNDC": "14445-014",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Apixaban",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160720",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "APIXABAN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-03-08",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20-JUL-16"
},
{
"NDCCode": "14783-014-01",
"PackageDescription": "1 g in 1 PACKET (14783-014-01)",
"NDC11Code": "14783-0014-01",
"ProductNDC": "14783-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Lederm 35plus Jour",
"ProprietaryNameSuffix": "Spf 15 Facial Treatment Against First Signs Of Aging Day - Oily Skin",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD.",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": ".03; .05; .03; .05",
"StrengthUnit": "g/g; g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14789-014-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (14789-014-01) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "14789-0014-01",
"ProductNDC": "14789-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ephedrine Sulfate",
"NonProprietaryName": "Ephedrine Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150608",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nexus Pharmaceuticals Inc",
"SubstanceName": "EPHEDRINE SULFATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "16262-014-01",
"PackageDescription": "85714 TABLET in 1 BAG (16262-014-01) ",
"NDC11Code": "16262-0014-01",
"ProductNDC": "16262-014",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Sodium Alendronate",
"DosageFormName": "TABLET",
"StartMarketingDate": "20151019",
"EndMarketingDate": "20271130",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aesica Pharmaceuticals GmbH, Zwickau",
"SubstanceName": "ALENDRONIC ACID",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-11-27",
"StartMarketingDatePackage": "19-OCT-15",
"EndMarketingDatePackage": "30-NOV-27"
},
{
"NDCCode": "16714-014-01",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (16714-014-01) ",
"NDC11Code": "16714-0014-01",
"ProductNDC": "16714-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200501",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065063",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200501",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.",
"Description": "Amoxicillin and clavulanate potassium tablets, USP is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Amoxicillin and Clavulanate Potassium Tablets, USP: 1 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 2 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 3 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)."
},
{
"NDCCode": "17714-014-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (17714-014-01) ",
"NDC11Code": "17714-0014-01",
"ProductNDC": "17714-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Apap",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900114",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Advance Pharmaceutical Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2017-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900114",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches, 3 backache, 4 minor pain of arthritis, 5 the common cold, 6 toothache, 7 premenstrual and menstrual cramps, 8 temporarily reduces fever."
}
]
}
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<NDCList>
<NDC>
<NDCCode>66302-014-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BOX (66302-014-01) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>66302-0014-01</NDC11Code>
<ProductNDC>66302-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Unituxin</ProprietaryName>
<NonProprietaryName>Dinutuximab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150310</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125516</ApplicationNumber>
<LabelerName>United Therapeutics Corporation</LabelerName>
<SubstanceName>DINUTUXIMAB</SubstanceName>
<StrengthNumber>3.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Glycolipid Disialoganglioside-directed Antibody Interactions [MoA], Glycolipid Disialoganglioside-directed Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dinutuximab is a glycolipid disialoganglioside (GD2)-binding chimeric monoclonal antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG1 and light chain kappa. Dinutuximab is produced in the murine myeloma cell line, SP2/0 and has an approximate molecular weight of 150 kDa. Unituxin (dinutuximab) injection is a sterile, preservative-free, clear and colorless to slightly opalescent solution for intravenous infusion. Unituxin is supplied in single-dose vials of 17.5 mg/5 mL. Each mL of solution contains 3.5 mg of dinutuximab, and histidine (3.10 mg), polysorbate 20 (0.55 mg), sodium chloride (8.77 mg), and Water for Injection, USP; hydrochloric acid is added to adjust pH to 6.8.</Description>
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<NDC>
<NDCCode>66302-101-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX (66302-101-01) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>66302-0101-01</NDC11Code>
<ProductNDC>66302-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Remodulin</ProprietaryName>
<NonProprietaryName>Treprostinil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20020522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021272</ApplicationNumber>
<LabelerName>United Therapeutics Corporation</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).</IndicationAndUsage>
<Description>Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>66302-102-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX (66302-102-01) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>66302-0102-01</NDC11Code>
<ProductNDC>66302-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Remodulin</ProprietaryName>
<NonProprietaryName>Treprostinil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20020522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021272</ApplicationNumber>
<LabelerName>United Therapeutics Corporation</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).</IndicationAndUsage>
<Description>Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>66302-105-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX (66302-105-01) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>66302-0105-01</NDC11Code>
<ProductNDC>66302-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Remodulin</ProprietaryName>
<NonProprietaryName>Treprostinil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20020522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021272</ApplicationNumber>
<LabelerName>United Therapeutics Corporation</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).</IndicationAndUsage>
<Description>Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection.</Description>
</NDC>
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<IndicationAndUsage>Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).</IndicationAndUsage>
<Description>Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection.</Description>
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<IndicationAndUsage>Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).</IndicationAndUsage>
<Description>Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection.</Description>
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<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
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<ApplicationNumber>NDA021272</ApplicationNumber>
<LabelerName>United Therapeutics Corporation</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).</IndicationAndUsage>
<Description>Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>20230928</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021272</ApplicationNumber>
<LabelerName>United Therapeutics Corporation</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).</IndicationAndUsage>
<Description>Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>66302-120-01</NDCCode>
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<ProductNDC>66302-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Remodulin</ProprietaryName>
<NonProprietaryName>Treprostinil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021272</ApplicationNumber>
<LabelerName>United Therapeutics Corporation</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Remodulin is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).</IndicationAndUsage>
<Description>Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in eight strengths, containing 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is. Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>66302-206-01</NDCCode>
<PackageDescription>1 BOX in 1 KIT (66302-206-01) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE</PackageDescription>
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<ProductNDC>66302-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tyvaso</ProprietaryName>
<NonProprietaryName>Treprostinil</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090814</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022387</ApplicationNumber>
<LabelerName>United Therapeutics Corporation</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>1.74</StrengthNumber>
<StrengthUnit>mg/2.9mL</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tyvaso is a prostacyclin mimetic indicated for the treatment of: 1 Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). (1.1), 2 Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). (1.2).</IndicationAndUsage>
<Description>Tyvaso is a sterile formulation of treprostinil, a prostacyclin mimetic, intended for administration by oral inhalation using the Tyvaso Inhalation System. Tyvaso is supplied in 2.9 mL low density polyethylene (LDPE) ampules, containing 1.74 mg treprostinil (0.6 mg/mL). Each ampule also contains 18.9 mg sodium chloride, 18.3 mg sodium citrate dihydrate, 0.58 mg sodium hydroxide, 11.7 mg 1 N hydrochloric acid, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is.</Description>
</NDC>
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<NDC11Code>66302-0300-01</NDC11Code>
<ProductNDC>66302-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orenitram</ProprietaryName>
<NonProprietaryName>Treprostinil</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131220</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203496</ApplicationNumber>
<LabelerName>United Therapeutics Corporation</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 To delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%). (1.1).</IndicationAndUsage>
<Description>Orenitram is an extended-release osmotic tablet for oral administration. Orenitram is formulated as the diolamine salt of treprostinil, a tricyclic benzindene analogue of prostacyclin. The chemical name is Acetic acid, 2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]-, complexed with 2,2'-iminobis[ethanol] (1:1). The molecular formula is C23H34O5∙C4H11NO2, the molecular weight is 495.65, and it has the following structural formula. Orenitram tablets are formulated in five strengths, which contain 0.125 mg of treprostinil (equivalent to 0.159 mg treprostinil diolamine), 0.25 mg of treprostinil (equivalent to 0.317 mg treprostinil diolamine), 1 mg of treprostinil (equivalent to 1.27 mg treprostinil diolamine), 2.5 mg of treprostinil (equivalent to 3.17 mg treprostinil diolamine), or 5 mg of treprostinil (equivalent to 6.35 mg treprostinil diolamine). The formulations also contain xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol USP, iron oxide black, n-butyl alcohol, and propylene glycol. Orenitram is designed to release treprostinil at a near zero-order rate using an osmotic tablet technology. The tablet core is coated with a semi-permeable membrane and has a laser-drilled aperture through the membrane. Upon contact with water (e.g., after ingestion), the core tablet absorbs water through the semi-permeable membrane. The water dissolves the water-soluble treprostinil diolamine and the water-soluble osmotic excipients, which creates hydrostatic pressure within the membrane, eventually forcing the drug across the membrane at a controlled rate.</Description>
</NDC>
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<NDCCode>66302-302-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-302-01) </PackageDescription>
<NDC11Code>66302-0302-01</NDC11Code>
<ProductNDC>66302-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orenitram</ProprietaryName>
<NonProprietaryName>Treprostinil</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131220</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203496</ApplicationNumber>
<LabelerName>United Therapeutics Corporation</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 To delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%). (1.1).</IndicationAndUsage>
<Description>Orenitram is an extended-release osmotic tablet for oral administration. Orenitram is formulated as the diolamine salt of treprostinil, a tricyclic benzindene analogue of prostacyclin. The chemical name is Acetic acid, 2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]-, complexed with 2,2'-iminobis[ethanol] (1:1). The molecular formula is C23H34O5∙C4H11NO2, the molecular weight is 495.65, and it has the following structural formula. Orenitram tablets are formulated in five strengths, which contain 0.125 mg of treprostinil (equivalent to 0.159 mg treprostinil diolamine), 0.25 mg of treprostinil (equivalent to 0.317 mg treprostinil diolamine), 1 mg of treprostinil (equivalent to 1.27 mg treprostinil diolamine), 2.5 mg of treprostinil (equivalent to 3.17 mg treprostinil diolamine), or 5 mg of treprostinil (equivalent to 6.35 mg treprostinil diolamine). The formulations also contain xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol USP, iron oxide black, n-butyl alcohol, and propylene glycol. Orenitram is designed to release treprostinil at a near zero-order rate using an osmotic tablet technology. The tablet core is coated with a semi-permeable membrane and has a laser-drilled aperture through the membrane. Upon contact with water (e.g., after ingestion), the core tablet absorbs water through the semi-permeable membrane. The water dissolves the water-soluble treprostinil diolamine and the water-soluble osmotic excipients, which creates hydrostatic pressure within the membrane, eventually forcing the drug across the membrane at a controlled rate.</Description>
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<IndicationAndUsage>Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 To delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%). (1.1).</IndicationAndUsage>
<Description>Orenitram is an extended-release osmotic tablet for oral administration. Orenitram is formulated as the diolamine salt of treprostinil, a tricyclic benzindene analogue of prostacyclin. The chemical name is Acetic acid, 2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]-, complexed with 2,2'-iminobis[ethanol] (1:1). The molecular formula is C23H34O5∙C4H11NO2, the molecular weight is 495.65, and it has the following structural formula. Orenitram tablets are formulated in five strengths, which contain 0.125 mg of treprostinil (equivalent to 0.159 mg treprostinil diolamine), 0.25 mg of treprostinil (equivalent to 0.317 mg treprostinil diolamine), 1 mg of treprostinil (equivalent to 1.27 mg treprostinil diolamine), 2.5 mg of treprostinil (equivalent to 3.17 mg treprostinil diolamine), or 5 mg of treprostinil (equivalent to 6.35 mg treprostinil diolamine). The formulations also contain xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol USP, iron oxide black, n-butyl alcohol, and propylene glycol. Orenitram is designed to release treprostinil at a near zero-order rate using an osmotic tablet technology. The tablet core is coated with a semi-permeable membrane and has a laser-drilled aperture through the membrane. Upon contact with water (e.g., after ingestion), the core tablet absorbs water through the semi-permeable membrane. The water dissolves the water-soluble treprostinil diolamine and the water-soluble osmotic excipients, which creates hydrostatic pressure within the membrane, eventually forcing the drug across the membrane at a controlled rate.</Description>
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<IndicationAndUsage>Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 To delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%). (1.1).</IndicationAndUsage>
<Description>Orenitram is an extended-release osmotic tablet for oral administration. Orenitram is formulated as the diolamine salt of treprostinil, a tricyclic benzindene analogue of prostacyclin. The chemical name is Acetic acid, 2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]-, complexed with 2,2'-iminobis[ethanol] (1:1). The molecular formula is C23H34O5∙C4H11NO2, the molecular weight is 495.65, and it has the following structural formula. Orenitram tablets are formulated in five strengths, which contain 0.125 mg of treprostinil (equivalent to 0.159 mg treprostinil diolamine), 0.25 mg of treprostinil (equivalent to 0.317 mg treprostinil diolamine), 1 mg of treprostinil (equivalent to 1.27 mg treprostinil diolamine), 2.5 mg of treprostinil (equivalent to 3.17 mg treprostinil diolamine), or 5 mg of treprostinil (equivalent to 6.35 mg treprostinil diolamine). The formulations also contain xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol USP, iron oxide black, n-butyl alcohol, and propylene glycol. Orenitram is designed to release treprostinil at a near zero-order rate using an osmotic tablet technology. The tablet core is coated with a semi-permeable membrane and has a laser-drilled aperture through the membrane. Upon contact with water (e.g., after ingestion), the core tablet absorbs water through the semi-permeable membrane. The water dissolves the water-soluble treprostinil diolamine and the water-soluble osmotic excipients, which creates hydrostatic pressure within the membrane, eventually forcing the drug across the membrane at a controlled rate.</Description>
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<IndicationAndUsage>Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 To delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%). (1.1).</IndicationAndUsage>
<Description>Orenitram is an extended-release osmotic tablet for oral administration. Orenitram is formulated as the diolamine salt of treprostinil, a tricyclic benzindene analogue of prostacyclin. The chemical name is Acetic acid, 2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]-, complexed with 2,2'-iminobis[ethanol] (1:1). The molecular formula is C23H34O5∙C4H11NO2, the molecular weight is 495.65, and it has the following structural formula. Orenitram tablets are formulated in five strengths, which contain 0.125 mg of treprostinil (equivalent to 0.159 mg treprostinil diolamine), 0.25 mg of treprostinil (equivalent to 0.317 mg treprostinil diolamine), 1 mg of treprostinil (equivalent to 1.27 mg treprostinil diolamine), 2.5 mg of treprostinil (equivalent to 3.17 mg treprostinil diolamine), or 5 mg of treprostinil (equivalent to 6.35 mg treprostinil diolamine). The formulations also contain xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol USP, iron oxide black, n-butyl alcohol, and propylene glycol. Orenitram is designed to release treprostinil at a near zero-order rate using an osmotic tablet technology. The tablet core is coated with a semi-permeable membrane and has a laser-drilled aperture through the membrane. Upon contact with water (e.g., after ingestion), the core tablet absorbs water through the semi-permeable membrane. The water dissolves the water-soluble treprostinil diolamine and the water-soluble osmotic excipients, which creates hydrostatic pressure within the membrane, eventually forcing the drug across the membrane at a controlled rate.</Description>
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<ProprietaryNameSuffix>Cc Broad Spectrum Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide</NonProprietaryName>
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<LastUpdate>2020-11-20</LastUpdate>
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<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078962</ApplicationNumber>
<LabelerName>KVK-TECH, INC.</LabelerName>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Betaxolol tablets, USP is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics.</IndicationAndUsage>
<Description>Betaxolol hydrochloride is a ß 1-selective (cardioselective) adrenergic receptor blocking agent available as 10-mg and 20-mg tablets for oral administration. Betaxolol hydrochloride is chemically described as 2-propanol, 1- [4-[2-(cyclopropylmethoxy) ethyl] phenoxy]-3-[(1-methylethyl) amino]-, hydrochloride, (±)-. It has the following chemical structure:. Each tablet for oral administration contains 10 mg or 20 mg of betaxolol hydrochloride equivalent to 8.94 mg or 17.88 mg of betaxolol respectively. In addition, each tablet contains the following inactive ingredients, hypromellose, anhydrous lactose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, stearic acid and titanium dioxide. Betaxolol hydrochloride is a water-soluble white crystalline powder with a molecular formula of C 18H 29NO 3HCl and a molecular weight of 343.9. It is freely soluble in water, ethanol, chloroform, and methanol, and has a pKa of 9.4.</Description>
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<LabelerName>MEDICAL-TECHNICAL GASES, INC.</LabelerName>
<SubstanceName>CARBON DIOXIDE</SubstanceName>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
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<LabelerName>Reese Pharmaceutical Co</LabelerName>
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<SamplePackage>N</SamplePackage>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20230228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
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<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.</IndicationAndUsage>
<Description>Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is:. Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg, as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate.</Description>
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<NDC11Code>13733-0014-01</NDC11Code>
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<ProprietaryName>Missha All Around Safe Block Essence Sun</ProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ABLE C&C CO., LTD.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; ENSULIZOLE</SubstanceName>
<StrengthNumber>3.5; 2.4; 2</StrengthNumber>
<StrengthUnit>mL/50mL; mL/50mL; mL/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INDICATION AND USAGE:- At the last step of basic skin care, apply an appropriate amount evenly over the face. Pat lightly until fully absorbed. - Apply evenly onto the face, neck, arms and legs where sun exposure occurs.- Reapply during long exposure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14141-014-01</NDCCode>
<PackageDescription>1 CASE in 1 BOX (14141-014-01) > 9 g in 1 CASE</PackageDescription>
<NDC11Code>14141-0014-01</NDC11Code>
<ProductNDC>14141-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 300-n</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A.</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>75; 78.4</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14445-014-01</NDCCode>
<PackageDescription>.1 kg in 1 DRUM (14445-014-01) </PackageDescription>
<NDC11Code>14445-0014-01</NDC11Code>
<ProductNDC>14445-014</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Apixaban</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160720</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>APIXABAN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-03-08</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-JUL-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14783-014-01</NDCCode>
<PackageDescription>1 g in 1 PACKET (14783-014-01)</PackageDescription>
<NDC11Code>14783-0014-01</NDC11Code>
<ProductNDC>14783-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Lederm 35plus Jour</ProprietaryName>
<ProprietaryNameSuffix>Spf 15 Facial Treatment Against First Signs Of Aging Day - Oily Skin</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD.</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>.03; .05; .03; .05</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14789-014-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (14789-014-01) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>14789-0014-01</NDC11Code>
<ProductNDC>14789-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ephedrine Sulfate</ProprietaryName>
<NonProprietaryName>Ephedrine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150608</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nexus Pharmaceuticals Inc</LabelerName>
<SubstanceName>EPHEDRINE SULFATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16262-014-01</NDCCode>
<PackageDescription>85714 TABLET in 1 BAG (16262-014-01) </PackageDescription>
<NDC11Code>16262-0014-01</NDC11Code>
<ProductNDC>16262-014</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Sodium Alendronate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20151019</StartMarketingDate>
<EndMarketingDate>20271130</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aesica Pharmaceuticals GmbH, Zwickau</LabelerName>
<SubstanceName>ALENDRONIC ACID</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-11-27</LastUpdate>
<StartMarketingDatePackage>19-OCT-15</StartMarketingDatePackage>
<EndMarketingDatePackage>30-NOV-27</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>16714-014-01</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (16714-014-01) </PackageDescription>
<NDC11Code>16714-0014-01</NDC11Code>
<ProductNDC>16714-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065063</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium tablets, USP is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Amoxicillin and Clavulanate Potassium Tablets, USP: 1 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 2 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 3 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium).</Description>
</NDC>
<NDC>
<NDCCode>17714-014-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (17714-014-01) </PackageDescription>
<NDC11Code>17714-0014-01</NDC11Code>
<ProductNDC>17714-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Apap</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900114</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Advance Pharmaceutical Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2017-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches, 3 backache, 4 minor pain of arthritis, 5 the common cold, 6 toothache, 7 premenstrual and menstrual cramps, 8 temporarily reduces fever.</IndicationAndUsage>
</NDC>
</NDCList>