{
"NDC": [
{
"NDCCode": "65649-551-07",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (65649-551-07) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE",
"NDC11Code": "65649-0551-07",
"ProductNDC": "65649-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Relistor",
"NonProprietaryName": "Methylnaltrexone Bromide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20080424",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021964",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "METHYLNALTREXONE BROMIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/.6mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080424",
"SamplePackage": "N",
"IndicationAndUsage": "RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1.1) . RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. (1.2) .",
"Description": "RELISTOR® (methylnaltrexone bromide) is a mu-opioid receptor antagonist. The chemical name for methylnaltrexone bromide is (R)-N-(cyclopropylmethyl) noroxymorphone methobromide. The molecular formula is C21H26NO4Br, and the molecular weight is 436.36. The structural formula is. RELISTOR tablets for oral administration are film-coated and contain 150 mg of methylnaltrexone bromide (equivalent to 122.5 mg methylnaltrexone). Inactive ingredients are silicified microcrystalline cellulose, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, crospovidone, poloxamer 407, stearic acid (vegetable source), colloidal silicon dioxide, edetate calcium disodium, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. RELISTOR for subcutaneous administration is a sterile, clear and colorless to pale yellow aqueous solution. Each 3 mL vial contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride. During manufacture, the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Each 8 mg/0.4 mL pre-filled syringe (1 mL syringe) contains 8 mg of methylnaltrexone bromide (equivalent to 6.5 mg of methylnaltrexone) in 0.4 mL of water. The excipients are 2.6 mg sodium chloride USP, 0.16 mg edetate calcium disodium USP, and 0.12 mg glycine hydrochloride. Each 12 mg/0.6 mL pre-filled syringe (1 mL syringe) contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride."
},
{
"NDCCode": "65649-003-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (65649-003-07) / 7 TABLET in 1 BOTTLE",
"NDC11Code": "65649-0003-07",
"ProductNDC": "65649-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trulance",
"ProprietaryNameSuffix": "Immediate Release",
"NonProprietaryName": "Plecanatide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170221",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208745",
"LabelerName": "Salix Pharmaceuticals Inc.",
"SubstanceName": "PLECANATIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170221",
"SamplePackage": "Y",
"IndicationAndUsage": "TRULANCE is indicated in adults for the treatment of: 1 chronic idiopathic constipation (CIC)., 2 irritable bowel syndrome with constipation (IBS-C).",
"Description": "TRULANCE (plecanatide) is a guanylate cyclase-C (GC-C) agonist. Plecanatide is a 16 amino acid peptide with the following chemical name: L-Leucine, L-asparaginyl-L-α-aspartyl-L-α-glutamyl-L-cysteinyl-L-α-glutamyl-L-leucyl-L-cysteinyl-L-valyl-L-asparaginyl-L-valyl-L-alanyl-L-cysteinyl-L-threonylglycyl-L-cysteinyl-, cyclic (4→12),(7→15)-bis(disulfide). The molecular formula of plecanatide is C 65H 104N 18O 26S 4and the molecular weight is 1682 Daltons. The amino acid sequence for plecanatide is shown below:. The solid lines linking cysteines illustrate disulfide bridges. Plecanatide is an amorphous, white to off-white powder. It is soluble in water. TRULANCE tablets are supplied as 3 mg tablets for oral administration. The inactive ingredients are magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "65649-551-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "65649-0551-02",
"ProductNDC": "65649-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Relistor",
"NonProprietaryName": "Methylnaltrexone Bromide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20080424",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021964",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "METHYLNALTREXONE BROMIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/.6mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080424",
"SamplePackage": "N",
"IndicationAndUsage": "RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1.1) . RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. (1.2) .",
"Description": "RELISTOR® (methylnaltrexone bromide) is a mu-opioid receptor antagonist. The chemical name for methylnaltrexone bromide is (R)-N-(cyclopropylmethyl) noroxymorphone methobromide. The molecular formula is C21H26NO4Br, and the molecular weight is 436.36. The structural formula is. RELISTOR tablets for oral administration are film-coated and contain 150 mg of methylnaltrexone bromide (equivalent to 122.5 mg methylnaltrexone). Inactive ingredients are silicified microcrystalline cellulose, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, crospovidone, poloxamer 407, stearic acid (vegetable source), colloidal silicon dioxide, edetate calcium disodium, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. RELISTOR for subcutaneous administration is a sterile, clear and colorless to pale yellow aqueous solution. Each 3 mL vial contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride. During manufacture, the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Each 8 mg/0.4 mL pre-filled syringe (1 mL syringe) contains 8 mg of methylnaltrexone bromide (equivalent to 6.5 mg of methylnaltrexone) in 0.4 mL of water. The excipients are 2.6 mg sodium chloride USP, 0.16 mg edetate calcium disodium USP, and 0.12 mg glycine hydrochloride. Each 12 mg/0.6 mL pre-filled syringe (1 mL syringe) contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride."
},
{
"NDCCode": "65649-551-03",
"PackageDescription": "7 BLISTER PACK in 1 CARTON (65649-551-03) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE",
"NDC11Code": "65649-0551-03",
"ProductNDC": "65649-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Relistor",
"NonProprietaryName": "Methylnaltrexone Bromide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20080424",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021964",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "METHYLNALTREXONE BROMIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/.6mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080424",
"SamplePackage": "N",
"IndicationAndUsage": "RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1.1) . RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. (1.2) .",
"Description": "RELISTOR® (methylnaltrexone bromide) is a mu-opioid receptor antagonist. The chemical name for methylnaltrexone bromide is (R)-N-(cyclopropylmethyl) noroxymorphone methobromide. The molecular formula is C21H26NO4Br, and the molecular weight is 436.36. The structural formula is. RELISTOR tablets for oral administration are film-coated and contain 150 mg of methylnaltrexone bromide (equivalent to 122.5 mg methylnaltrexone). Inactive ingredients are silicified microcrystalline cellulose, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, crospovidone, poloxamer 407, stearic acid (vegetable source), colloidal silicon dioxide, edetate calcium disodium, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. RELISTOR for subcutaneous administration is a sterile, clear and colorless to pale yellow aqueous solution. Each 3 mL vial contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride. During manufacture, the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Each 8 mg/0.4 mL pre-filled syringe (1 mL syringe) contains 8 mg of methylnaltrexone bromide (equivalent to 6.5 mg of methylnaltrexone) in 0.4 mL of water. The excipients are 2.6 mg sodium chloride USP, 0.16 mg edetate calcium disodium USP, and 0.12 mg glycine hydrochloride. Each 12 mg/0.6 mL pre-filled syringe (1 mL syringe) contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride."
},
{
"NDCCode": "65649-551-06",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (65649-551-06) > 1 SYRINGE in 1 BLISTER PACK > .6 mL in 1 SYRINGE",
"NDC11Code": "65649-0551-06",
"ProductNDC": "65649-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Relistor",
"NonProprietaryName": "Methylnaltrexone Bromide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20080424",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021964",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "METHYLNALTREXONE BROMIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/.6mL",
"Pharm_Classes": "Opioid Antagonist [EPC],Opioid Antagonists [MoA],Quaternary Ammonium Compounds [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20080424",
"SamplePackage": "N"
},
{
"NDCCode": "53489-551-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-551-07) ",
"NDC11Code": "53489-0551-07",
"ProductNDC": "53489-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20011129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075998",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20011129",
"SamplePackage": "N"
},
{
"NDCCode": "55319-551-07",
"PackageDescription": "7 BLISTER PACK in 1 CARTON (55319-551-07) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55319-0551-07",
"ProductNDC": "55319-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207342",
"LabelerName": "Family Dollar (FAMILY WELLNESS)",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive."
},
{
"NDCCode": "59630-551-07",
"PackageDescription": "1 DOSE PACK in 1 CARTON (59630-551-07) > 7 TABLET, FILM COATED in 1 DOSE PACK",
"NDC11Code": "59630-0551-07",
"ProductNDC": "59630-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mulpleta",
"NonProprietaryName": "Lusutrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180827",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210923",
"LabelerName": "SHIONOGI INC.",
"SubstanceName": "LUSUTROMBOPAG",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2020-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180827",
"SamplePackage": "N",
"IndicationAndUsage": "MULPLETA is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.",
"Description": "MULPLETA (lusutrombopag), a thrombopoietin (TPO) receptor agonist, contains lusutrombopag as the active ingredient. The chemical name for lusutrombopag is (2 E)-3-{2,6-Dichloro-4-[(4-{3-[(1 S)-1-(hexyloxy) ethyl]-2-methoxyphenyl}-1,3-thiazol-2-yl) carbamoyl]phenyl}-2-methylprop-2-enoic acid. The structural formula is. The empirical formula for lusutrombopag is C 29H 32Cl 2N 2O 5S and the molecular weight is 591.54. Lusutrombopag is a white to slightly yellowish white powder, and is freely soluble in N,N-dimethylformamide, slightly soluble in ethanol (99.5%) and methanol, very slightly soluble in acetonitrile, and practically insoluble in water. Lusutrombopag is slightly soluble in the buffer solution at pH 11 and practically insoluble in buffer solutions with pH ranges of 1 to 9. MULPLETA (lusutrombopag) tablets for oral use contain lusutrombopag 3 mg. Excipients are D-mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate, hydroxypropyl cellulose, carboxymethylcellulose calcium, magnesium stearate, hypromellose, triethyl citrate, titanium dioxide, red ferric oxide, and talc."
},
{
"NDCCode": "71919-551-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-551-07) ",
"NDC11Code": "71919-0551-07",
"ProductNDC": "71919-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Podophyllum Peltatum",
"NonProprietaryName": "Podophyllum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100630",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "PODOPHYLLUM",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100630",
"SamplePackage": "N"
},
{
"NDCCode": "84230-551-07",
"PackageDescription": "1 DOSE PACK in 1 CARTON (84230-551-07) / 7 TABLET, FILM COATED in 1 DOSE PACK",
"NDC11Code": "84230-0551-07",
"ProductNDC": "84230-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mulpleta",
"NonProprietaryName": "Lusutrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210923",
"LabelerName": "VANCOCIN ITALIA SRL",
"SubstanceName": "LUSUTROMBOPAG",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251209",
"SamplePackage": "N",
"IndicationAndUsage": "MULPLETA is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.",
"Description": "MULPLETA (lusutrombopag), a thrombopoietin (TPO) receptor agonist, contains lusutrombopag as the active ingredient. The chemical name for lusutrombopag is (2 E)-3-{2,6-Dichloro-4-[(4-{3-[(1 S)-1-(hexyloxy) ethyl]-2-methoxyphenyl}-1,3-thiazol-2-yl) carbamoyl]phenyl}-2-methylprop-2-enoic acid. The structural formula is. The empirical formula for lusutrombopag is C 29H 32Cl 2N 2O 5S and the molecular weight is 591.54. Lusutrombopag is a white to slightly yellowish white powder, and is freely soluble in N,N-dimethylformamide, slightly soluble in ethanol (99.5%) and methanol, very slightly soluble in acetonitrile, and practically insoluble in water. Lusutrombopag is slightly soluble in the buffer solution at pH 11 and practically insoluble in buffer solutions with pH ranges of 1 to 9. MULPLETA (lusutrombopag) tablets for oral use contain lusutrombopag 3 mg. Excipients are D-mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate, hydroxypropyl cellulose, carboxymethylcellulose calcium, magnesium stearate, hypromellose, triethyl citrate, titanium dioxide, red ferric oxide, and talc."
},
{
"NDCCode": "85320-551-07",
"PackageDescription": "1 DOSE PACK in 1 CARTON (85320-551-07) / 7 TABLET, FILM COATED in 1 DOSE PACK",
"NDC11Code": "85320-0551-07",
"ProductNDC": "85320-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mulpleta",
"NonProprietaryName": "Lusutrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251124",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210923",
"LabelerName": "Eddingpharm (U. S. ) Inc.",
"SubstanceName": "LUSUTROMBOPAG",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251124",
"SamplePackage": "N",
"IndicationAndUsage": "MULPLETA is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.",
"Description": "MULPLETA (lusutrombopag), a thrombopoietin (TPO) receptor agonist, contains lusutrombopag as the active ingredient. The chemical name for lusutrombopag is (2 E)-3-{2,6-Dichloro-4-[(4-{3-[(1 S)-1-(hexyloxy) ethyl]-2-methoxyphenyl}-1,3-thiazol-2-yl) carbamoyl]phenyl}-2-methylprop-2-enoic acid. The structural formula is. The empirical formula for lusutrombopag is C 29H 32Cl 2N 2O 5S and the molecular weight is 591.54. Lusutrombopag is a white to slightly yellowish white powder, and is freely soluble in N,N-dimethylformamide, slightly soluble in ethanol (99.5%) and methanol, very slightly soluble in acetonitrile, and practically insoluble in water. Lusutrombopag is slightly soluble in the buffer solution at pH 11 and practically insoluble in buffer solutions with pH ranges of 1 to 9. MULPLETA (lusutrombopag) tablets for oral use contain lusutrombopag 3 mg. Excipients are D-mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate, hydroxypropyl cellulose, carboxymethylcellulose calcium, magnesium stearate, hypromellose, triethyl citrate, titanium dioxide, red ferric oxide, and talc."
},
{
"NDCCode": "42291-551-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42291-551-60) ",
"NDC11Code": "42291-0551-60",
"ProductNDC": "42291-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090041",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160111",
"SamplePackage": "N"
},
{
"NDCCode": "46708-551-30",
"PackageDescription": "1 TUBE in 1 CARTON (46708-551-30) / 30 g in 1 TUBE",
"NDC11Code": "46708-0551-30",
"ProductNDC": "46708-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213414",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DAPSONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.",
"Description": "Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water."
},
{
"NDCCode": "46708-551-60",
"PackageDescription": "1 TUBE in 1 CARTON (46708-551-60) / 60 g in 1 TUBE",
"NDC11Code": "46708-0551-60",
"ProductNDC": "46708-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213414",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DAPSONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.",
"Description": "Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water."
},
{
"NDCCode": "46708-551-90",
"PackageDescription": "1 TUBE in 1 CARTON (46708-551-90) / 90 g in 1 TUBE",
"NDC11Code": "46708-0551-90",
"ProductNDC": "46708-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213414",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DAPSONE",
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"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.",
"Description": "Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water."
},
{
"NDCCode": "50580-551-01",
"PackageDescription": "1 KIT in 1 PACKAGE (50580-551-01) * 2 BLISTER PACK in 1 KIT / 8 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 KIT / 4 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50580-0551-01",
"ProductNDC": "50580-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Tylenol Severe Cough Plus Sore Throat Day/night",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Chlorpheniramine Maleate",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20240826",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Kenvue Brands LLC",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240826",
"SamplePackage": "N"
},
{
"NDCCode": "50804-551-02",
"PackageDescription": "1 KIT in 1 CARTON (50804-551-02) * 12 TABLET, COATED in 1 BLISTER PACK * 8 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "50804-0551-02",
"ProductNDC": "50804-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold Multi-symptom Daytime And Nighttime",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20111231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "GoodSense",
"Status": "Active",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111231",
"SamplePackage": "N"
},
{
"NDCCode": "54860-551-01",
"PackageDescription": "28 mL in 1 BOTTLE, SPRAY (54860-551-01) ",
"NDC11Code": "54860-0551-01",
"ProductNDC": "54860-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Care Hand Sanitizer Monster Jam",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260105",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Shenzhen Lantern Scicence Co.,Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260105",
"SamplePackage": "Y",
"IndicationAndUsage": "Adults and children 6 years and older Spray onto hands and rub together unil dry. Recommended for repeat use. Children under 6 years of age should be supervised when using this product."
},
{
"NDCCode": "54868-5772-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54868-5772-0)",
"NDC11Code": "54868-5772-00",
"ProductNDC": "54868-5772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tekturna",
"NonProprietaryName": "Aliskiren Hemifumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070523",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021985",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ALISKIREN HEMIFUMARATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Renin Inhibitor [EPC],Renin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tekturna is a renin inhibitor (RI) indicated for: 1 The treatment of hypertension, to lower blood pressure (1.1).",
"Description": "Tekturna contains aliskiren hemifumarate, a renin inhibitor, that is provided as tablets for oral administration. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water."
},
{
"NDCCode": "54868-6041-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54868-6041-0)",
"NDC11Code": "54868-6041-00",
"ProductNDC": "54868-6041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tekturna Hct",
"NonProprietaryName": "Aliskiren Hemifumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090615",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022107",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "150; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tekturna HCT is indicated for the treatment of hypertension. Add-On Therapy. A patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with Tekturna HCT. A patient whose blood pressure is controlled with hydrochlorothiazide alone but who experiences hypokalemia may be switched to combination therapy with Tekturna HCT. A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Tekturna HCT containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. Replacement Therapy. Tekturna HCT may be substituted for the titrated components. Initial Therapy. Tekturna HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Tekturna HCT as initial therapy should be based on an assessment of potential benefits and risks. Patients with Stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high-dose multifactorial study [see Clinical Studies (14)] provides estimates of the probability of reaching a target blood pressure with Tekturna HCT compared to aliskiren or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Tekturna HCT 300/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. At all levels of baseline blood pressure, the probability of achieving any given diastolic or systolic goal is greater with the combination than for either monotherapy. For example, the mean baseline msSBP/msDBP for patients participating in this multifactorial study was 154/99 mmHg. A patient with a baseline blood pressure of 154/99 mmHg has about a 62% chance of achieving a goal of <140 mmHg (systolic) and 61% chance of achieving <90 mmHg (diastolic) on aliskiren alone, and the chance of achieving these goals on hydrochlorothiazide alone is about 54% (systolic) and 49% (diastolic). The chance of achieving these goals on Tekturna HCT rises to about 77% (systolic) and 74% (diastolic). The chance of achieving these goals on placebo is about 34% (systolic) and 37% (diastolic). [See Dosage and Administration (2) and Clinical Studies (14).].",
"Description": "Tekturna HCT is a fixed combination of aliskiren, an orally active, nonpeptide, direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic. Aliskiren. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-Carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-Octanol, and highly soluble in water. Hydrochlorothiazide. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Tekturna HCT tablets are formulated for oral administration to contain aliskiren and hydrochlorothiazide, USP 150/12.5 mg, 150/25 mg, 300/12.5 mg and 300/25 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide colorants, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide, and wheat starch."
},
{
"NDCCode": "54868-6042-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54868-6042-0)",
"NDC11Code": "54868-6042-00",
"ProductNDC": "54868-6042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tekturna",
"NonProprietaryName": "Aliskiren Hemifumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090622",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021985",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ALISKIREN HEMIFUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Renin Inhibitor [EPC],Renin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tekturna is a renin inhibitor (RI) indicated for: 1 The treatment of hypertension, to lower blood pressure (1.1).",
"Description": "Tekturna contains aliskiren hemifumarate, a renin inhibitor, that is provided as tablets for oral administration. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water."
},
{
"NDCCode": "54868-6103-0",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (54868-6103-0)",
"NDC11Code": "54868-6103-00",
"ProductNDC": "54868-6103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tekturna Hct",
"NonProprietaryName": "Aliskiren Hemifumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100413",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022107",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "300; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tekturna HCT is indicated for the treatment of hypertension. Add-On Therapy. A patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with Tekturna HCT. A patient whose blood pressure is controlled with hydrochlorothiazide alone but who experiences hypokalemia may be switched to combination therapy with Tekturna HCT. A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Tekturna HCT containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. Replacement Therapy. Tekturna HCT may be substituted for the titrated components. Initial Therapy. Tekturna HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Tekturna HCT as initial therapy should be based on an assessment of potential benefits and risks. Patients with Stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high-dose multifactorial study [see Clinical Studies (14)] provides estimates of the probability of reaching a target blood pressure with Tekturna HCT compared to aliskiren or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Tekturna HCT 300/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. At all levels of baseline blood pressure, the probability of achieving any given diastolic or systolic goal is greater with the combination than for either monotherapy. For example, the mean baseline msSBP/msDBP for patients participating in this multifactorial study was 154/99 mmHg. A patient with a baseline blood pressure of 154/99 mmHg has about a 62% chance of achieving a goal of <140 mmHg (systolic) and 61% chance of achieving <90 mmHg (diastolic) on aliskiren alone, and the chance of achieving these goals on hydrochlorothiazide alone is about 54% (systolic) and 49% (diastolic). The chance of achieving these goals on Tekturna HCT rises to about 77% (systolic) and 74% (diastolic). The chance of achieving these goals on placebo is about 34% (systolic) and 37% (diastolic). [See Dosage and Administration (2) and Clinical Studies (14).].",
"Description": "Tekturna HCT is a fixed combination of aliskiren, an orally active, nonpeptide, direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic. Aliskiren. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-Carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-Octanol, and highly soluble in water. Hydrochlorothiazide. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Tekturna HCT tablets are formulated for oral administration to contain aliskiren and hydrochlorothiazide, USP 150/12.5 mg, 150/25 mg, 300/12.5 mg and 300/25 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide colorants, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide, and wheat starch."
},
{
"NDCCode": "54868-6194-0",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-6194-0)",
"NDC11Code": "54868-6194-00",
"ProductNDC": "54868-6194",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tekturna Hct",
"NonProprietaryName": "Aliskiren Hemifumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101103",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022107",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "300; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tekturna HCT is indicated for the treatment of hypertension. Add-On Therapy. A patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with Tekturna HCT. A patient whose blood pressure is controlled with hydrochlorothiazide alone but who experiences hypokalemia may be switched to combination therapy with Tekturna HCT. A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Tekturna HCT containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. Replacement Therapy. Tekturna HCT may be substituted for the titrated components. Initial Therapy. Tekturna HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Tekturna HCT as initial therapy should be based on an assessment of potential benefits and risks. Patients with Stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high-dose multifactorial study [see Clinical Studies (14)] provides estimates of the probability of reaching a target blood pressure with Tekturna HCT compared to aliskiren or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Tekturna HCT 300/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. At all levels of baseline blood pressure, the probability of achieving any given diastolic or systolic goal is greater with the combination than for either monotherapy. For example, the mean baseline msSBP/msDBP for patients participating in this multifactorial study was 154/99 mmHg. A patient with a baseline blood pressure of 154/99 mmHg has about a 62% chance of achieving a goal of <140 mmHg (systolic) and 61% chance of achieving <90 mmHg (diastolic) on aliskiren alone, and the chance of achieving these goals on hydrochlorothiazide alone is about 54% (systolic) and 49% (diastolic). The chance of achieving these goals on Tekturna HCT rises to about 77% (systolic) and 74% (diastolic). The chance of achieving these goals on placebo is about 34% (systolic) and 37% (diastolic). [See Dosage and Administration (2) and Clinical Studies (14).].",
"Description": "Tekturna HCT is a fixed combination of aliskiren, an orally active, nonpeptide, direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic. Aliskiren. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-Carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-Octanol, and highly soluble in water. Hydrochlorothiazide. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Tekturna HCT tablets are formulated for oral administration to contain aliskiren and hydrochlorothiazide, USP 150/12.5 mg, 150/25 mg, 300/12.5 mg and 300/25 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide colorants, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide, and wheat starch."
},
{
"NDCCode": "55910-551-48",
"PackageDescription": "283 g in 1 BOTTLE (55910-551-48) ",
"NDC11Code": "55910-0551-48",
"ProductNDC": "55910-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dg Health",
"ProprietaryNameSuffix": "Sugar Free",
"NonProprietaryName": "Fiber Therapy Psyllium Husk",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20190516",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "DOLGENCORP, LLC",
"SubstanceName": "PSYLLIUM HUSK",
"StrengthNumber": "3.4",
"StrengthUnit": "g/5.8g",
"Status": "Deprecated",
"LastUpdate": "2023-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190516",
"SamplePackage": "N"
},
{
"NDCCode": "60760-551-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (60760-551-30)",
"NDC11Code": "60760-0551-30",
"ProductNDC": "60760-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ambien Cr",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021774",
"LabelerName": "St Marys Medical Park Pharmacy",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "61786-551-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (61786-551-02) ",
"NDC11Code": "61786-0551-02",
"ProductNDC": "61786-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Guanfacine",
"NonProprietaryName": "Guanfacine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074673",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "GUANFACINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160125",
"SamplePackage": "N"
},
{
"NDCCode": "62332-551-30",
"PackageDescription": "1 TUBE in 1 CARTON (62332-551-30) / 30 g in 1 TUBE",
"NDC11Code": "62332-0551-30",
"ProductNDC": "62332-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213414",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "DAPSONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.",
"Description": "Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water."
},
{
"NDCCode": "62332-551-60",
"PackageDescription": "1 TUBE in 1 CARTON (62332-551-60) / 60 g in 1 TUBE",
"NDC11Code": "62332-0551-60",
"ProductNDC": "62332-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213414",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "DAPSONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.",
"Description": "Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water."
},
{
"NDCCode": "62332-551-90",
"PackageDescription": "1 TUBE in 1 CARTON (62332-551-90) / 90 g in 1 TUBE",
"NDC11Code": "62332-0551-90",
"ProductNDC": "62332-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213414",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "DAPSONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
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"IndicationAndUsage": "Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.",
"Description": "Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water."
},
{
"NDCCode": "63354-551-54",
"PackageDescription": "170 g in 1 BOTTLE (63354-551-54) ",
"NDC11Code": "63354-0551-54",
"ProductNDC": "63354-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hawaiian Tropic Silk Hydration Sunscreen Broad Spectrum Spf 30",
"NonProprietaryName": "Avobenzone,homosalate,octisalate,octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201023",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Edgewell Personal Care Brands, LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "2; 5.5; 4.5; 4",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201023",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
}
]
}
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<NDCList>
<NDC>
<NDCCode>65649-551-07</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (65649-551-07) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>65649-0551-07</NDC11Code>
<ProductNDC>65649-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Relistor</ProprietaryName>
<NonProprietaryName>Methylnaltrexone Bromide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20080424</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021964</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHYLNALTREXONE BROMIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/.6mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1.1) . RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. (1.2) .</IndicationAndUsage>
<Description>RELISTOR® (methylnaltrexone bromide) is a mu-opioid receptor antagonist. The chemical name for methylnaltrexone bromide is (R)-N-(cyclopropylmethyl) noroxymorphone methobromide. The molecular formula is C21H26NO4Br, and the molecular weight is 436.36. The structural formula is. RELISTOR tablets for oral administration are film-coated and contain 150 mg of methylnaltrexone bromide (equivalent to 122.5 mg methylnaltrexone). Inactive ingredients are silicified microcrystalline cellulose, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, crospovidone, poloxamer 407, stearic acid (vegetable source), colloidal silicon dioxide, edetate calcium disodium, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. RELISTOR for subcutaneous administration is a sterile, clear and colorless to pale yellow aqueous solution. Each 3 mL vial contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride. During manufacture, the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Each 8 mg/0.4 mL pre-filled syringe (1 mL syringe) contains 8 mg of methylnaltrexone bromide (equivalent to 6.5 mg of methylnaltrexone) in 0.4 mL of water. The excipients are 2.6 mg sodium chloride USP, 0.16 mg edetate calcium disodium USP, and 0.12 mg glycine hydrochloride. Each 12 mg/0.6 mL pre-filled syringe (1 mL syringe) contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride.</Description>
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<NDC>
<NDCCode>65649-003-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65649-003-07) / 7 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>65649-0003-07</NDC11Code>
<ProductNDC>65649-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trulance</ProprietaryName>
<ProprietaryNameSuffix>Immediate Release</ProprietaryNameSuffix>
<NonProprietaryName>Plecanatide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170221</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208745</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PLECANATIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170221</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TRULANCE is indicated in adults for the treatment of: 1 chronic idiopathic constipation (CIC)., 2 irritable bowel syndrome with constipation (IBS-C).</IndicationAndUsage>
<Description>TRULANCE (plecanatide) is a guanylate cyclase-C (GC-C) agonist. Plecanatide is a 16 amino acid peptide with the following chemical name: L-Leucine, L-asparaginyl-L-α-aspartyl-L-α-glutamyl-L-cysteinyl-L-α-glutamyl-L-leucyl-L-cysteinyl-L-valyl-L-asparaginyl-L-valyl-L-alanyl-L-cysteinyl-L-threonylglycyl-L-cysteinyl-, cyclic (4→12),(7→15)-bis(disulfide). The molecular formula of plecanatide is C 65H 104N 18O 26S 4and the molecular weight is 1682 Daltons. The amino acid sequence for plecanatide is shown below:. The solid lines linking cysteines illustrate disulfide bridges. Plecanatide is an amorphous, white to off-white powder. It is soluble in water. TRULANCE tablets are supplied as 3 mg tablets for oral administration. The inactive ingredients are magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>65649-551-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>65649-0551-02</NDC11Code>
<ProductNDC>65649-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Relistor</ProprietaryName>
<NonProprietaryName>Methylnaltrexone Bromide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20080424</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021964</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHYLNALTREXONE BROMIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/.6mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<Description>RELISTOR® (methylnaltrexone bromide) is a mu-opioid receptor antagonist. The chemical name for methylnaltrexone bromide is (R)-N-(cyclopropylmethyl) noroxymorphone methobromide. The molecular formula is C21H26NO4Br, and the molecular weight is 436.36. The structural formula is. RELISTOR tablets for oral administration are film-coated and contain 150 mg of methylnaltrexone bromide (equivalent to 122.5 mg methylnaltrexone). Inactive ingredients are silicified microcrystalline cellulose, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, crospovidone, poloxamer 407, stearic acid (vegetable source), colloidal silicon dioxide, edetate calcium disodium, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. RELISTOR for subcutaneous administration is a sterile, clear and colorless to pale yellow aqueous solution. Each 3 mL vial contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride. During manufacture, the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Each 8 mg/0.4 mL pre-filled syringe (1 mL syringe) contains 8 mg of methylnaltrexone bromide (equivalent to 6.5 mg of methylnaltrexone) in 0.4 mL of water. The excipients are 2.6 mg sodium chloride USP, 0.16 mg edetate calcium disodium USP, and 0.12 mg glycine hydrochloride. Each 12 mg/0.6 mL pre-filled syringe (1 mL syringe) contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>65649-551-03</NDCCode>
<PackageDescription>7 BLISTER PACK in 1 CARTON (65649-551-03) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>65649-0551-03</NDC11Code>
<ProductNDC>65649-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Relistor</ProprietaryName>
<NonProprietaryName>Methylnaltrexone Bromide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20080424</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021964</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHYLNALTREXONE BROMIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/.6mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1.1) . RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. (1.2) .</IndicationAndUsage>
<Description>RELISTOR® (methylnaltrexone bromide) is a mu-opioid receptor antagonist. The chemical name for methylnaltrexone bromide is (R)-N-(cyclopropylmethyl) noroxymorphone methobromide. The molecular formula is C21H26NO4Br, and the molecular weight is 436.36. The structural formula is. RELISTOR tablets for oral administration are film-coated and contain 150 mg of methylnaltrexone bromide (equivalent to 122.5 mg methylnaltrexone). Inactive ingredients are silicified microcrystalline cellulose, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, crospovidone, poloxamer 407, stearic acid (vegetable source), colloidal silicon dioxide, edetate calcium disodium, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. RELISTOR for subcutaneous administration is a sterile, clear and colorless to pale yellow aqueous solution. Each 3 mL vial contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride. During manufacture, the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Each 8 mg/0.4 mL pre-filled syringe (1 mL syringe) contains 8 mg of methylnaltrexone bromide (equivalent to 6.5 mg of methylnaltrexone) in 0.4 mL of water. The excipients are 2.6 mg sodium chloride USP, 0.16 mg edetate calcium disodium USP, and 0.12 mg glycine hydrochloride. Each 12 mg/0.6 mL pre-filled syringe (1 mL syringe) contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>65649-551-06</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (65649-551-06) > 1 SYRINGE in 1 BLISTER PACK > .6 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>65649-0551-06</NDC11Code>
<ProductNDC>65649-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Relistor</ProprietaryName>
<NonProprietaryName>Methylnaltrexone Bromide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20080424</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021964</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHYLNALTREXONE BROMIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/.6mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC],Opioid Antagonists [MoA],Quaternary Ammonium Compounds [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53489-551-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-551-07) </PackageDescription>
<NDC11Code>53489-0551-07</NDC11Code>
<ProductNDC>53489-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075998</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20011129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55319-551-07</NDCCode>
<PackageDescription>7 BLISTER PACK in 1 CARTON (55319-551-07) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55319-0551-07</NDC11Code>
<ProductNDC>55319-551</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207342</ApplicationNumber>
<LabelerName>Family Dollar (FAMILY WELLNESS)</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59630-551-07</NDCCode>
<PackageDescription>1 DOSE PACK in 1 CARTON (59630-551-07) > 7 TABLET, FILM COATED in 1 DOSE PACK</PackageDescription>
<NDC11Code>59630-0551-07</NDC11Code>
<ProductNDC>59630-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mulpleta</ProprietaryName>
<NonProprietaryName>Lusutrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180827</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210923</ApplicationNumber>
<LabelerName>SHIONOGI INC.</LabelerName>
<SubstanceName>LUSUTROMBOPAG</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2020-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MULPLETA is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.</IndicationAndUsage>
<Description>MULPLETA (lusutrombopag), a thrombopoietin (TPO) receptor agonist, contains lusutrombopag as the active ingredient. The chemical name for lusutrombopag is (2 E)-3-{2,6-Dichloro-4-[(4-{3-[(1 S)-1-(hexyloxy) ethyl]-2-methoxyphenyl}-1,3-thiazol-2-yl) carbamoyl]phenyl}-2-methylprop-2-enoic acid. The structural formula is. The empirical formula for lusutrombopag is C 29H 32Cl 2N 2O 5S and the molecular weight is 591.54. Lusutrombopag is a white to slightly yellowish white powder, and is freely soluble in N,N-dimethylformamide, slightly soluble in ethanol (99.5%) and methanol, very slightly soluble in acetonitrile, and practically insoluble in water. Lusutrombopag is slightly soluble in the buffer solution at pH 11 and practically insoluble in buffer solutions with pH ranges of 1 to 9. MULPLETA (lusutrombopag) tablets for oral use contain lusutrombopag 3 mg. Excipients are D-mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate, hydroxypropyl cellulose, carboxymethylcellulose calcium, magnesium stearate, hypromellose, triethyl citrate, titanium dioxide, red ferric oxide, and talc.</Description>
</NDC>
<NDC>
<NDCCode>71919-551-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-551-07) </PackageDescription>
<NDC11Code>71919-0551-07</NDC11Code>
<ProductNDC>71919-551</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Podophyllum Peltatum</ProprietaryName>
<NonProprietaryName>Podophyllum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100630</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>PODOPHYLLUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84230-551-07</NDCCode>
<PackageDescription>1 DOSE PACK in 1 CARTON (84230-551-07) / 7 TABLET, FILM COATED in 1 DOSE PACK</PackageDescription>
<NDC11Code>84230-0551-07</NDC11Code>
<ProductNDC>84230-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mulpleta</ProprietaryName>
<NonProprietaryName>Lusutrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251209</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210923</ApplicationNumber>
<LabelerName>VANCOCIN ITALIA SRL</LabelerName>
<SubstanceName>LUSUTROMBOPAG</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MULPLETA is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.</IndicationAndUsage>
<Description>MULPLETA (lusutrombopag), a thrombopoietin (TPO) receptor agonist, contains lusutrombopag as the active ingredient. The chemical name for lusutrombopag is (2 E)-3-{2,6-Dichloro-4-[(4-{3-[(1 S)-1-(hexyloxy) ethyl]-2-methoxyphenyl}-1,3-thiazol-2-yl) carbamoyl]phenyl}-2-methylprop-2-enoic acid. The structural formula is. The empirical formula for lusutrombopag is C 29H 32Cl 2N 2O 5S and the molecular weight is 591.54. Lusutrombopag is a white to slightly yellowish white powder, and is freely soluble in N,N-dimethylformamide, slightly soluble in ethanol (99.5%) and methanol, very slightly soluble in acetonitrile, and practically insoluble in water. Lusutrombopag is slightly soluble in the buffer solution at pH 11 and practically insoluble in buffer solutions with pH ranges of 1 to 9. MULPLETA (lusutrombopag) tablets for oral use contain lusutrombopag 3 mg. Excipients are D-mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate, hydroxypropyl cellulose, carboxymethylcellulose calcium, magnesium stearate, hypromellose, triethyl citrate, titanium dioxide, red ferric oxide, and talc.</Description>
</NDC>
<NDC>
<NDCCode>85320-551-07</NDCCode>
<PackageDescription>1 DOSE PACK in 1 CARTON (85320-551-07) / 7 TABLET, FILM COATED in 1 DOSE PACK</PackageDescription>
<NDC11Code>85320-0551-07</NDC11Code>
<ProductNDC>85320-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mulpleta</ProprietaryName>
<NonProprietaryName>Lusutrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251124</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210923</ApplicationNumber>
<LabelerName>Eddingpharm (U. S. ) Inc.</LabelerName>
<SubstanceName>LUSUTROMBOPAG</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MULPLETA is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.</IndicationAndUsage>
<Description>MULPLETA (lusutrombopag), a thrombopoietin (TPO) receptor agonist, contains lusutrombopag as the active ingredient. The chemical name for lusutrombopag is (2 E)-3-{2,6-Dichloro-4-[(4-{3-[(1 S)-1-(hexyloxy) ethyl]-2-methoxyphenyl}-1,3-thiazol-2-yl) carbamoyl]phenyl}-2-methylprop-2-enoic acid. The structural formula is. The empirical formula for lusutrombopag is C 29H 32Cl 2N 2O 5S and the molecular weight is 591.54. Lusutrombopag is a white to slightly yellowish white powder, and is freely soluble in N,N-dimethylformamide, slightly soluble in ethanol (99.5%) and methanol, very slightly soluble in acetonitrile, and practically insoluble in water. Lusutrombopag is slightly soluble in the buffer solution at pH 11 and practically insoluble in buffer solutions with pH ranges of 1 to 9. MULPLETA (lusutrombopag) tablets for oral use contain lusutrombopag 3 mg. Excipients are D-mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate, hydroxypropyl cellulose, carboxymethylcellulose calcium, magnesium stearate, hypromellose, triethyl citrate, titanium dioxide, red ferric oxide, and talc.</Description>
</NDC>
<NDC>
<NDCCode>42291-551-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42291-551-60) </PackageDescription>
<NDC11Code>42291-0551-60</NDC11Code>
<ProductNDC>42291-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090041</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46708-551-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (46708-551-30) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>46708-0551-30</NDC11Code>
<ProductNDC>46708-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213414</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>46708-551-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (46708-551-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>46708-0551-60</NDC11Code>
<ProductNDC>46708-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213414</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>46708-551-90</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (46708-551-90) / 90 g in 1 TUBE</PackageDescription>
<NDC11Code>46708-0551-90</NDC11Code>
<ProductNDC>46708-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213414</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>50580-551-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (50580-551-01) * 2 BLISTER PACK in 1 KIT / 8 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 KIT / 4 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50580-0551-01</NDC11Code>
<ProductNDC>50580-551</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Tylenol Severe Cough Plus Sore Throat Day/night</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50804-551-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (50804-551-02) * 12 TABLET, COATED in 1 BLISTER PACK * 8 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50804-0551-02</NDC11Code>
<ProductNDC>50804-551</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold Multi-symptom Daytime And Nighttime</ProprietaryName>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20111231</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>GoodSense</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54860-551-01</NDCCode>
<PackageDescription>28 mL in 1 BOTTLE, SPRAY (54860-551-01) </PackageDescription>
<NDC11Code>54860-0551-01</NDC11Code>
<ProductNDC>54860-551</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care Hand Sanitizer Monster Jam</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Shenzhen Lantern Scicence Co.,Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260105</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Adults and children 6 years and older Spray onto hands and rub together unil dry. Recommended for repeat use. Children under 6 years of age should be supervised when using this product.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54868-5772-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (54868-5772-0)</PackageDescription>
<NDC11Code>54868-5772-00</NDC11Code>
<ProductNDC>54868-5772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tekturna</ProprietaryName>
<NonProprietaryName>Aliskiren Hemifumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070523</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021985</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>ALISKIREN HEMIFUMARATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Renin Inhibitor [EPC],Renin Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tekturna is a renin inhibitor (RI) indicated for: 1 The treatment of hypertension, to lower blood pressure (1.1).</IndicationAndUsage>
<Description>Tekturna contains aliskiren hemifumarate, a renin inhibitor, that is provided as tablets for oral administration. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>54868-6041-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (54868-6041-0)</PackageDescription>
<NDC11Code>54868-6041-00</NDC11Code>
<ProductNDC>54868-6041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tekturna Hct</ProprietaryName>
<NonProprietaryName>Aliskiren Hemifumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090615</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022107</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>150; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tekturna HCT is indicated for the treatment of hypertension. Add-On Therapy. A patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with Tekturna HCT. A patient whose blood pressure is controlled with hydrochlorothiazide alone but who experiences hypokalemia may be switched to combination therapy with Tekturna HCT. A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Tekturna HCT containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. Replacement Therapy. Tekturna HCT may be substituted for the titrated components. Initial Therapy. Tekturna HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Tekturna HCT as initial therapy should be based on an assessment of potential benefits and risks. Patients with Stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high-dose multifactorial study [see Clinical Studies (14)] provides estimates of the probability of reaching a target blood pressure with Tekturna HCT compared to aliskiren or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Tekturna HCT 300/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. At all levels of baseline blood pressure, the probability of achieving any given diastolic or systolic goal is greater with the combination than for either monotherapy. For example, the mean baseline msSBP/msDBP for patients participating in this multifactorial study was 154/99 mmHg. A patient with a baseline blood pressure of 154/99 mmHg has about a 62% chance of achieving a goal of <140 mmHg (systolic) and 61% chance of achieving <90 mmHg (diastolic) on aliskiren alone, and the chance of achieving these goals on hydrochlorothiazide alone is about 54% (systolic) and 49% (diastolic). The chance of achieving these goals on Tekturna HCT rises to about 77% (systolic) and 74% (diastolic). The chance of achieving these goals on placebo is about 34% (systolic) and 37% (diastolic). [See Dosage and Administration (2) and Clinical Studies (14).].</IndicationAndUsage>
<Description>Tekturna HCT is a fixed combination of aliskiren, an orally active, nonpeptide, direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic. Aliskiren. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-Carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-Octanol, and highly soluble in water. Hydrochlorothiazide. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Tekturna HCT tablets are formulated for oral administration to contain aliskiren and hydrochlorothiazide, USP 150/12.5 mg, 150/25 mg, 300/12.5 mg and 300/25 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide colorants, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide, and wheat starch.</Description>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
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<IndicationAndUsage>Tekturna is a renin inhibitor (RI) indicated for: 1 The treatment of hypertension, to lower blood pressure (1.1).</IndicationAndUsage>
<Description>Tekturna contains aliskiren hemifumarate, a renin inhibitor, that is provided as tablets for oral administration. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water.</Description>
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<IndicationAndUsage>Tekturna HCT is indicated for the treatment of hypertension. Add-On Therapy. A patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with Tekturna HCT. A patient whose blood pressure is controlled with hydrochlorothiazide alone but who experiences hypokalemia may be switched to combination therapy with Tekturna HCT. A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Tekturna HCT containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. Replacement Therapy. Tekturna HCT may be substituted for the titrated components. Initial Therapy. Tekturna HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Tekturna HCT as initial therapy should be based on an assessment of potential benefits and risks. Patients with Stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high-dose multifactorial study [see Clinical Studies (14)] provides estimates of the probability of reaching a target blood pressure with Tekturna HCT compared to aliskiren or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Tekturna HCT 300/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. At all levels of baseline blood pressure, the probability of achieving any given diastolic or systolic goal is greater with the combination than for either monotherapy. For example, the mean baseline msSBP/msDBP for patients participating in this multifactorial study was 154/99 mmHg. A patient with a baseline blood pressure of 154/99 mmHg has about a 62% chance of achieving a goal of <140 mmHg (systolic) and 61% chance of achieving <90 mmHg (diastolic) on aliskiren alone, and the chance of achieving these goals on hydrochlorothiazide alone is about 54% (systolic) and 49% (diastolic). The chance of achieving these goals on Tekturna HCT rises to about 77% (systolic) and 74% (diastolic). The chance of achieving these goals on placebo is about 34% (systolic) and 37% (diastolic). [See Dosage and Administration (2) and Clinical Studies (14).].</IndicationAndUsage>
<Description>Tekturna HCT is a fixed combination of aliskiren, an orally active, nonpeptide, direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic. Aliskiren. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-Carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-Octanol, and highly soluble in water. Hydrochlorothiazide. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Tekturna HCT tablets are formulated for oral administration to contain aliskiren and hydrochlorothiazide, USP 150/12.5 mg, 150/25 mg, 300/12.5 mg and 300/25 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide colorants, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide, and wheat starch.</Description>
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<IndicationAndUsage>Tekturna HCT is indicated for the treatment of hypertension. Add-On Therapy. A patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with Tekturna HCT. A patient whose blood pressure is controlled with hydrochlorothiazide alone but who experiences hypokalemia may be switched to combination therapy with Tekturna HCT. A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Tekturna HCT containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. Replacement Therapy. Tekturna HCT may be substituted for the titrated components. Initial Therapy. Tekturna HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Tekturna HCT as initial therapy should be based on an assessment of potential benefits and risks. Patients with Stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high-dose multifactorial study [see Clinical Studies (14)] provides estimates of the probability of reaching a target blood pressure with Tekturna HCT compared to aliskiren or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Tekturna HCT 300/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. At all levels of baseline blood pressure, the probability of achieving any given diastolic or systolic goal is greater with the combination than for either monotherapy. For example, the mean baseline msSBP/msDBP for patients participating in this multifactorial study was 154/99 mmHg. A patient with a baseline blood pressure of 154/99 mmHg has about a 62% chance of achieving a goal of <140 mmHg (systolic) and 61% chance of achieving <90 mmHg (diastolic) on aliskiren alone, and the chance of achieving these goals on hydrochlorothiazide alone is about 54% (systolic) and 49% (diastolic). The chance of achieving these goals on Tekturna HCT rises to about 77% (systolic) and 74% (diastolic). The chance of achieving these goals on placebo is about 34% (systolic) and 37% (diastolic). [See Dosage and Administration (2) and Clinical Studies (14).].</IndicationAndUsage>
<Description>Tekturna HCT is a fixed combination of aliskiren, an orally active, nonpeptide, direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic. Aliskiren. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-Carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-Octanol, and highly soluble in water. Hydrochlorothiazide. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Tekturna HCT tablets are formulated for oral administration to contain aliskiren and hydrochlorothiazide, USP 150/12.5 mg, 150/25 mg, 300/12.5 mg and 300/25 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide colorants, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide, and wheat starch.</Description>
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<IndicationAndUsage>Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water.</Description>
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<IndicationAndUsage>Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>63354-551-54</NDCCode>
<PackageDescription>170 g in 1 BOTTLE (63354-551-54) </PackageDescription>
<NDC11Code>63354-0551-54</NDC11Code>
<ProductNDC>63354-551</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hawaiian Tropic Silk Hydration Sunscreen Broad Spectrum Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone,homosalate,octisalate,octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201023</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Edgewell Personal Care Brands, LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>2; 5.5; 4.5; 4</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
</NDCList>