{
"NDC": [
{
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"RouteName": "TOPICAL",
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"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Two Hip Consulting, LLC",
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"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]",
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"StartMarketingDatePackage": "20120818",
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"IndicationAndUsage": "USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS."
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{
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"PackageDescription": "120 mL in 1 TUBE (76074-121-14)",
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"ProductNDC": "76074-121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi-derm Topical Pain Relief",
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"RouteName": "TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Two Hip Consulting, LLC",
"SubstanceName": "METHYL SALICYLATE; MENTHOL; CAPSAICIN",
"StrengthNumber": "20; 5; .0355",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "76074-122-14",
"PackageDescription": "120 mL in 1 TUBE (76074-122-14) ",
"NDC11Code": "76074-0122-14",
"ProductNDC": "76074-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi-sulting Topical Pain Relief",
"NonProprietaryName": "Methyl Salicylate Menthol Capsaicin Lidocaine",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20120818",
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"ApplicationNumber": "part348",
"LabelerName": "Two Hip Consulting, LLC",
"SubstanceName": "METHYL SALICYLATE; MENTHOL; CAPSAICIN; LIDOCAINE",
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"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20120818",
"SamplePackage": "N",
"IndicationAndUsage": "USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS."
},
{
"NDCCode": "76074-132-14",
"PackageDescription": "120 mL in 1 TUBE (76074-132-14)",
"NDC11Code": "76074-0132-14",
"ProductNDC": "76074-132",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi-derm / L",
"ProprietaryNameSuffix": "With Lidocaine",
"NonProprietaryName": "Methyl Salicylate Menthol Capsaicin Lidocaine",
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"RouteName": "TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Two Hip Consulting, LLC",
"SubstanceName": "METHYL SALICYLATE; MENTHOL; CAPSAICIN; LIDOCAINE",
"StrengthNumber": "20; 5; .0355; 4",
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"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "76074-140-14",
"PackageDescription": "120 mL in 1 TUBE (76074-140-14)",
"NDC11Code": "76074-0140-14",
"ProductNDC": "76074-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topical Pain Relief",
"ProprietaryNameSuffix": "Rx",
"NonProprietaryName": "Methyl Salicylate Menthol Capsaicin",
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"LabelerName": "Two Hip Consulting, LLC",
"SubstanceName": "METHYL SALICYLATE; MENTHOL; CAPSAICIN",
"StrengthNumber": "20; 5; .0355",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "76074-141-14",
"PackageDescription": "120 mL in 1 TUBE (76074-141-14)",
"NDC11Code": "76074-0141-14",
"ProductNDC": "76074-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doloracin",
"ProprietaryNameSuffix": "Rx",
"NonProprietaryName": "Methyl Salicylate, Menthol And Capsaicin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130811",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Two Hip Consulting, LLC",
"SubstanceName": "METHYL SALICYLATE; MENTHOL; CAPSAICIN",
"StrengthNumber": "20; 5; .035",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "76074-142-14",
"PackageDescription": "120 mL in 1 TUBE (76074-142-14)",
"NDC11Code": "76074-0142-14",
"ProductNDC": "76074-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doloracin/l Rx",
"ProprietaryNameSuffix": "With Lidocaine",
"NonProprietaryName": "Methyl Salicylate, Menthol, Capsaicin And Lidocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130731",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Two Hip Consulting, LLC",
"SubstanceName": "METHYL SALICYLATE; MENTHOL; CAPSAICIN; LIDOCAINE",
"StrengthNumber": "20; 5; .035; 4",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "76074-151-14",
"PackageDescription": "120 mL in 1 TUBE (76074-151-14) ",
"NDC11Code": "76074-0151-14",
"ProductNDC": "76074-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20120818",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Two Hip Consulting, LLC",
"SubstanceName": "METHYL SALICYLATE; MENTHOL; CAPSAICIN",
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"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20120818",
"SamplePackage": "N",
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{
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"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070033",
"LabelerName": "STAT Rx USA LLC",
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"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
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"IndicationAndUsage": "Metronidazole, USP is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).",
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},
{
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"NDC11Code": "37000-0152-14",
"ProductNDC": "37000-152",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Old Spice Wild Collection",
"ProprietaryNameSuffix": "Lionpride Invisible",
"NonProprietaryName": "Aluminum Zirconium Trichlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130730",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY",
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"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2015-06-16"
},
{
"NDCCode": "47046-152-02",
"PackageDescription": "1 TUBE in 1 BOX (47046-152-02) > 14 g in 1 TUBE (47046-152-01) ",
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"ProductTypeName": "HUMAN OTC DRUG",
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"NonProprietaryName": "Miconazole Nitrate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
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"ApplicationNumber": "part333C",
"LabelerName": "Anicare Pharmaceuticals Pvt. Ltd",
"SubstanceName": "MICONAZOLE NITRATE",
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"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201209",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 cures most athlete's foot, jock itch, and ringworm., 2 relieves itching, burning, cracking, scaling and discomfort which accompany these conditions."
},
{
"NDCCode": "53329-152-04",
"PackageDescription": "4.14 mL in 1 PACKET (53329-152-04) ",
"NDC11Code": "53329-0152-04",
"ProductNDC": "53329-152",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medline Remedy Phytoplex Skin Repair",
"NonProprietaryName": "Dimethicone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180212",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Medline Industries, LP",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180212",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve chapped or cracked skin. Protects from the drying effects of wind and cold weather."
},
{
"NDCCode": "53329-152-14",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medline Remedy Phytoplex Skin Repair",
"NonProprietaryName": "Dimethicone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180212",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Medline Industries, LP",
"SubstanceName": "DIMETHICONE",
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"StrengthUnit": "g/100mL",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180212",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve chapped or cracked skin. Protects from the drying effects of wind and cold weather."
},
{
"NDCCode": "53329-152-17",
"PackageDescription": "144 PACKET in 1 BOX (53329-152-17) / 4.14 mL in 1 PACKET (53329-152-04) ",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20180212",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Medline Industries, LP",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180403",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve chapped or cracked skin. Protects from the drying effects of wind and cold weather."
},
{
"NDCCode": "61919-152-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (61919-152-14)",
"NDC11Code": "61919-0152-14",
"ProductNDC": "61919-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070044",
"LabelerName": "DIRECT RX",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-15",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0008-1210-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1210-30) ",
"NDC11Code": "00008-1210-30",
"ProductNDC": "0008-1210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pristiq",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Desvenlafaxine Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021992",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150401",
"SamplePackage": "N",
"IndicationAndUsage": "PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
"Description": "PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2∙C4H6O4∙H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. PRISTIQ is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 50 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 100 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide and FD&C yellow #6."
},
{
"NDCCode": "0008-1211-01",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-01) ",
"NDC11Code": "00008-1211-01",
"ProductNDC": "0008-1211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pristiq",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Desvenlafaxine Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021992",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080501",
"SamplePackage": "N",
"IndicationAndUsage": "PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
"Description": "PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2∙C4H6O4∙H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. PRISTIQ is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 50 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 100 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide and FD&C yellow #6."
},
{
"NDCCode": "0008-1211-14",
"PackageDescription": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-14) ",
"NDC11Code": "00008-1211-14",
"ProductNDC": "0008-1211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pristiq",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Desvenlafaxine Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021992",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080501",
"SamplePackage": "N",
"IndicationAndUsage": "PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
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"Description": "PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2∙C4H6O4∙H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. PRISTIQ is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 50 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 100 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide and FD&C yellow #6."
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"Description": "PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2∙C4H6O4∙H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. PRISTIQ is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 50 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 100 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide and FD&C yellow #6."
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"Description": "PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2∙C4H6O4∙H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. PRISTIQ is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 50 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 100 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide and FD&C yellow #6."
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"IndicationAndUsage": "Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
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"IndicationAndUsage": "Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
"Description": "Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated 4-[2-(dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]phenol succinate and has the molecular formula of C16H25NO2C4H6O4 (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is not pH dependent. The solubility in water is about 50 mg per mL. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration containing 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium stearyl fumarate. In addition to the ingredients listed above, the 25 mg tablets are film-coated with Opadry II Beige film-coating which contains FD&C Red No. 40, FD&C Yellow No. 6, FD&C Blue No. 1, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg and 100 mg tablets are film-coated with Opadry II Orange film-coating which contains: FD&C Red No. 40, FD&C Yellow No. 6, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide."
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"LabelerName": "Hikma Pharmaceuticals USA Inc.",
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"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170301",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
"Description": "Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated 4-[2-(dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]phenol succinate and has the molecular formula of C16H25NO2C4H6O4 (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is not pH dependent. The solubility in water is about 50 mg per mL. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration containing 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium stearyl fumarate. In addition to the ingredients listed above, the 25 mg tablets are film-coated with Opadry II Beige film-coating which contains FD&C Red No. 40, FD&C Yellow No. 6, FD&C Blue No. 1, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg and 100 mg tablets are film-coated with Opadry II Orange film-coating which contains: FD&C Red No. 40, FD&C Yellow No. 6, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "0054-0401-22",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-22) ",
"NDC11Code": "00054-0401-22",
"ProductNDC": "0054-0401",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204083",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170301",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
"Description": "Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated 4-[2-(dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]phenol succinate and has the molecular formula of C16H25NO2C4H6O4 (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is not pH dependent. The solubility in water is about 50 mg per mL. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration containing 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium stearyl fumarate. In addition to the ingredients listed above, the 25 mg tablets are film-coated with Opadry II Beige film-coating which contains FD&C Red No. 40, FD&C Yellow No. 6, FD&C Blue No. 1, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg and 100 mg tablets are film-coated with Opadry II Orange film-coating which contains: FD&C Red No. 40, FD&C Yellow No. 6, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "0054-0603-13",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0603-13) ",
"NDC11Code": "00054-0603-13",
"ProductNDC": "0054-0603",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204083",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170829",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
"Description": "Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated 4-[2-(dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]phenol succinate and has the molecular formula of C16H25NO2C4H6O4 (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is not pH dependent. The solubility in water is about 50 mg per mL. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration containing 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium stearyl fumarate. In addition to the ingredients listed above, the 25 mg tablets are film-coated with Opadry II Beige film-coating which contains FD&C Red No. 40, FD&C Yellow No. 6, FD&C Blue No. 1, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg and 100 mg tablets are film-coated with Opadry II Orange film-coating which contains: FD&C Red No. 40, FD&C Yellow No. 6, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "0074-1044-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0074-1044-01) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00074-1044-01",
"ProductNDC": "0074-1044",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emrelis",
"NonProprietaryName": "Telisotuzumab Vedotin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761384",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "TELISOTUZUMAB VEDOTIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration (2.1)], who have received a prior systemic therapy. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "Telisotuzumab vedotin-tllv is a c-Met directed antibody-drug conjugate (ADC) comprised of a humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody conjugated to the small molecule microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a protease-cleavable valine-citrulline (vc) linker. The antibody is produced in a mammalian cell line (Chinese hamster ovary) and the drug-linker is produced by chemical synthesis. Each monoclonal antibody molecule carries an average of 3 MMAE molecules. Telisotuzumab vedotin-tllv has an approximate molecular weight of 152 kDa. EMRELIS (telisotuzumab vedotin-tllv) for injection is a sterile, white to off-white, preservative-free, lyophilized powder in a single-dose vial for reconstitution and dilution prior to intravenous infusion. EMRELIS is supplied as 20 mg per vial or 100 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.1 mL and 5.2 mL, respectively) to obtain a concentration of 20 mg/mL [see Dosage and Administration (2.4)]. Following reconstitution, each mL delivers 20 mg of telisotuzumab vedotin-tllv, and histidine (2.33 mg), polysorbate 80 (0.10 mg), sucrose (70.0 mg), and Water for Injection. Hydrochloric acid was added to adjust the pH to 6.0."
}
]
}
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<NDCList>
<NDC>
<NDCCode>76074-152-14</NDCCode>
<PackageDescription>120 mL in 1 TUBE (76074-152-14) </PackageDescription>
<NDC11Code>76074-0152-14</NDC11Code>
<ProductNDC>76074-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medi-derm / L With Lidocaine</ProprietaryName>
<ProprietaryNameSuffix>Rx</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate Menthol Capsaicin Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120818</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Two Hip Consulting, LLC</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL; CAPSAICIN; LIDOCAINE</SubstanceName>
<StrengthNumber>20; 5; .0355; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76074-121-14</NDCCode>
<PackageDescription>120 mL in 1 TUBE (76074-121-14)</PackageDescription>
<NDC11Code>76074-0121-14</NDC11Code>
<ProductNDC>76074-121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi-derm Topical Pain Relief</ProprietaryName>
<NonProprietaryName>Methyl Salicylate Menthol Capsaicin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Two Hip Consulting, LLC</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL; CAPSAICIN</SubstanceName>
<StrengthNumber>20; 5; .0355</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>76074-122-14</NDCCode>
<PackageDescription>120 mL in 1 TUBE (76074-122-14) </PackageDescription>
<NDC11Code>76074-0122-14</NDC11Code>
<ProductNDC>76074-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi-sulting Topical Pain Relief</ProprietaryName>
<NonProprietaryName>Methyl Salicylate Menthol Capsaicin Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120818</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Two Hip Consulting, LLC</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL; CAPSAICIN; LIDOCAINE</SubstanceName>
<StrengthNumber>20; 5; .0355; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76074-132-14</NDCCode>
<PackageDescription>120 mL in 1 TUBE (76074-132-14)</PackageDescription>
<NDC11Code>76074-0132-14</NDC11Code>
<ProductNDC>76074-132</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi-derm / L</ProprietaryName>
<ProprietaryNameSuffix>With Lidocaine</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate Menthol Capsaicin Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120818</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Two Hip Consulting, LLC</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL; CAPSAICIN; LIDOCAINE</SubstanceName>
<StrengthNumber>20; 5; .0355; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>76074-140-14</NDCCode>
<PackageDescription>120 mL in 1 TUBE (76074-140-14)</PackageDescription>
<NDC11Code>76074-0140-14</NDC11Code>
<ProductNDC>76074-140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topical Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Rx</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate Menthol Capsaicin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120818</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Two Hip Consulting, LLC</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL; CAPSAICIN</SubstanceName>
<StrengthNumber>20; 5; .0355</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>76074-141-14</NDCCode>
<PackageDescription>120 mL in 1 TUBE (76074-141-14)</PackageDescription>
<NDC11Code>76074-0141-14</NDC11Code>
<ProductNDC>76074-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doloracin</ProprietaryName>
<ProprietaryNameSuffix>Rx</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate, Menthol And Capsaicin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130811</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Two Hip Consulting, LLC</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL; CAPSAICIN</SubstanceName>
<StrengthNumber>20; 5; .035</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>76074-142-14</NDCCode>
<PackageDescription>120 mL in 1 TUBE (76074-142-14)</PackageDescription>
<NDC11Code>76074-0142-14</NDC11Code>
<ProductNDC>76074-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doloracin/l Rx</ProprietaryName>
<ProprietaryNameSuffix>With Lidocaine</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate, Menthol, Capsaicin And Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130731</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Two Hip Consulting, LLC</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL; CAPSAICIN; LIDOCAINE</SubstanceName>
<StrengthNumber>20; 5; .035; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>76074-151-14</NDCCode>
<PackageDescription>120 mL in 1 TUBE (76074-151-14) </PackageDescription>
<NDC11Code>76074-0151-14</NDC11Code>
<ProductNDC>76074-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medi-derm</ProprietaryName>
<ProprietaryNameSuffix>Rx</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate, Menthol And Capsaicin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120818</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Two Hip Consulting, LLC</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL; CAPSAICIN</SubstanceName>
<StrengthNumber>20; 5; .035</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16590-152-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (16590-152-14)</PackageDescription>
<NDC11Code>16590-0152-14</NDC11Code>
<ProductNDC>16590-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070033</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metronidazole, USP is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).</IndicationAndUsage>
<Description>Metronidazole, USP is an oral synthetic antiprotozoal and antibacterial agent, 1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole, which has the following structural formula. Each tablet for oral administration contains 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include microcrystalline cellulose, crospovidone, colloidal silicon dioxide and hydrogenated vegetable oil.</Description>
</NDC>
<NDC>
<NDCCode>37000-152-14</NDCCode>
<PackageDescription>14 g in 1 CANISTER (37000-152-14)</PackageDescription>
<NDC11Code>37000-0152-14</NDC11Code>
<ProductNDC>37000-152</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Old Spice Wild Collection</ProprietaryName>
<ProprietaryNameSuffix>Lionpride Invisible</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Trichlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130730</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>.18</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-06-16</LastUpdate>
</NDC>
<NDC>
<NDCCode>47046-152-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (47046-152-02) > 14 g in 1 TUBE (47046-152-01) </PackageDescription>
<NDC11Code>47046-0152-02</NDC11Code>
<ProductNDC>47046-152</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-fungal</ProprietaryName>
<NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>Anicare Pharmaceuticals Pvt. Ltd</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>.02</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ProductNDC>0074-1044</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emrelis</ProprietaryName>
<NonProprietaryName>Telisotuzumab Vedotin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250514</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761384</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>TELISOTUZUMAB VEDOTIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration (2.1)], who have received a prior systemic therapy. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>Telisotuzumab vedotin-tllv is a c-Met directed antibody-drug conjugate (ADC) comprised of a humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody conjugated to the small molecule microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a protease-cleavable valine-citrulline (vc) linker. The antibody is produced in a mammalian cell line (Chinese hamster ovary) and the drug-linker is produced by chemical synthesis. Each monoclonal antibody molecule carries an average of 3 MMAE molecules. Telisotuzumab vedotin-tllv has an approximate molecular weight of 152 kDa. EMRELIS (telisotuzumab vedotin-tllv) for injection is a sterile, white to off-white, preservative-free, lyophilized powder in a single-dose vial for reconstitution and dilution prior to intravenous infusion. EMRELIS is supplied as 20 mg per vial or 100 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.1 mL and 5.2 mL, respectively) to obtain a concentration of 20 mg/mL [see Dosage and Administration (2.4)]. Following reconstitution, each mL delivers 20 mg of telisotuzumab vedotin-tllv, and histidine (2.33 mg), polysorbate 80 (0.10 mg), sucrose (70.0 mg), and Water for Injection. Hydrochloric acid was added to adjust the pH to 6.0.</Description>
</NDC>
</NDCList>